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 (pCO2) analyzer
868.1200 indwelling blood oxygen partial pressure (pO2) 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
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 Parkinso nian tremor
Stimulator, sacral nerve, implanted
Stimulator, spinal-cord, totally implanted for pain relief
Stimulator, subcortical, implanted for epilepsy
Device, thermal ablation, endometrial
To find out the compliance status of specific medical devices, as reported by the device manufacturers, visit the following Web address: www.fda.gov/scripts/cdrh/ year2000/y2k_search.cfm. To see a list of names and addresses of manufacturers who have registered with the FDA, go to www.fda.gov/scripts/cdrh/cfdocs/cfrl/ registra/search.cfm.
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