Classified Devices

(Classification regulation number followed by classification name)

• 862.1345 — Glucose test system

• 862.2140 — Centrifugal chemistry analyzer for clinical use

• 862.2150 — Continuous flow sequential multiple chemistry analyzer for clinical use

• 862.2160 — Discrete photometric chemistry analyzer for clinical use

• 862.2170 — Micro chemistry analyzer for clinical use

• 868.1150 — Indwelling blood carbon dioxide partial pressure (pC0₂) analyzer

• 868.1200 — Indwelling blood oxygen partial pressure (p0₂) analyzer

• 868.1730 — Oxygen-uptake computer

• 868.2375 — Breathing frequency monitor

• 868.2450 — Lung water monitor

• 868.5160 — Gas machine for anesthesia or analgesia

• 868.5330 — Breathing gas mixer

• 868.5400 — Electroanesthesia apparatus

• 868.5440 — Portable oxygen generator

• 868.5470 — Hyperbaric chamber

• 868.5610 — Membrane lung (for long-term pulmonary support)

• 868.5830 — Autotransfusion apparatus

• 868.5880 — Anesthetic vaporizer

• 868.5895 — Continuous ventilator

• 868.5925 — Powered emergency ventilator

• 868.5935 — External negative pressure ventilator

• 868.5955 — Intermittent mandatory ventilation attachment

• 870.1025 — Arrhythmia detector and alarm

• 870.1750 — External programmable pacemaker pulse generator

• 870.3535 — Intra-aortic balloon and control system

• 870.3545 — Ventricular bypass (assist) device

• 870.3600 — External pacemaker pulse generator

• 870.3610 — Implantable pacemaker pulse generator

• 870.3700 — Pacemaker programmers

• 870.4220 — Cardiopulmonary bypass heart-lung machine console

• 870.4320 — Cardiopulmonary bypass pulsatile flow generator

• 870.4330 — Cardiopulmonary bypass on-line blood gas monitor

• 870.4360 — Nonroller-type cardiopulmonary bypass blood pump

• 870.4370 — Roller type cardiopulmonary bypass blood pump

• 870.4380 — Cardiopulmonary bypass pump speed control

• 870.5225 — External counter-pulsating device

• 870.5300 — DC-Defibrillator low energy (including paddles)

• 876.5270 — Implanted electrical urinary continence device

• 876.5630 — Peritoneal dialysis system and accessories

• 876.5820 — Hemodialysis systems and accessories

• 876.5860 — High-permeability hemodialysis system

• 876.5870 — Sorbent hemoperfusion system

• 876.5880 — Isolated kidney perfusion and transport system and accessories

• 880.5130 — Infant radiant warmer

• 880.5400 — Neonatal incubator

• 880.5410 — Neonatal transport incubator

• 880.5725 — Infusion pump

• 882.5820 — Implanted cerebellar stimulator

• 882.5830 — Implanted diaphragmatic/phrenic nerve stimulator

• 882.5840 — Implanted intracerebral/subcortical stimulator for pain relief

882.5850 — Implanted spinal cord stimulator for bladder evacuation

• 882.5860 — Implanted neuromuscular stimulator

• 882.5870 — Implanted peripheral nerve stimulator for pain relief

• 882.5880 — Implanted spinal cord stimulator for pain relief

• 884.1700 — Hysteroscopic insufflator

• 884.1730 — Laparoscopic insufflator

• 884.2660 — Fetal ultrasonic monitor and accessories

The following device classifications include radiation treatment planning systems that are accessories to these device types.

• 892.5050* — Medical charged-particle radiation therapy system

• 892.5300* — Medical neutron radiation therapy system

• 892.5700* — Remote controlled radionuclide-applicator system

• 892.5750* — Radionuclide radiation therapy system

• 892.5900* — X-ray radiation therapy system

*The above-specified device classifications include radiation treatment planning systems that are accessories to these device types.

Post-medical device amendments Class III devices, and devices not yet classified

• Ventilator, high frequency

• Cardioconverter, implantable

• Defibrillator, automatic implantable cardioverter

• Defibrillator, implantable, dual-chamber

• Pulse-generator, dual chamber, implantable

• Pulse-generator, program module

• Pulse-generator, single chamber, sensor-driven, implantable

• Pulse-generator, single chamber

• System, pacing, temporary, acute, internal atrial defibrillation

• Automated blood cell and plasma separator for therapeutic purposes

• Lipoprotein, low density, removal

• Separator for therapeutic purposes, membrane automated blood cell/plasma

• Pump, drug administration, closed loop

• Pump, infusion, implanted, programmable

• Kit, test, alpha-fetoprotein for neural tube defects

• Stimulator, cortical, implanted (for pain)

• Stimulator, electrical, implanted, for Parkinsonian tremor

• Stimulator, sacral nerve, implanted

• Stimulator, spinal cord, totally implanted for pain relief

• Stimulator, subcortical, implanted for epilepsy

• Device, thermal ablation, endometrial