FDA.reportPublic FDA data

Home-use sleep apnoea recording system

Definition
A battery-powered device intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea. It typically consists of multiple components including a control unit which may have some user-interface functionality, sensors, and connecting leads, which record parameters and may upload the data to a central analysis system.
GUDID devices
76
Last updated
2023-05-04 12:53:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03615220004133AccusomBIOSERENITY MEDICAL DEVICES GROUP1017-10001-US2023-04-26
03615220004140AccusomBIOSERENITY MEDICAL DEVICES GROUP1017-15014-US2023-04-26
03615220004157AccusomBIOSERENITY MEDICAL DEVICES GROUP1017-15004-US2023-04-26
00860512000260AccuSomNOVASOM, INC.1017-15004-US2023-01-13
00860512000277AccuSomNOVASOM, INC.1017-15014-US2023-01-13
00860512000291AccuSomNOVASOM, INC.1017-50003-US2023-01-13
00860512000253AccuSomNOVASOM, INC.1017-10001-US2023-01-13
00817111021189NomadAir PMU810 Portable RecorderNeurotronics, LLCPMU8102022-12-27
00817111021196NomadAir PMU810 RIP Belt, SmallNeurotronics, LLCPMU8102022-12-27
00817111021202NomadAir PMU810 RIP Belt, MediumNeurotronics, LLCPMU8102022-12-27
00817111021219NomadAir PMU810 RIP Belt, LargeNeurotronics, LLCPMU8102022-12-27
00850015266546Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.SP29-1002.LE(GER)2022-08-25
00840067103968CadwellCADWELL INDUSTRIES, INC.302522-200-10532022-04-07
00840067103579CadwellCADWELL INDUSTRIES, INC.302551-200-02002022-03-15
00840067103920CadwellCADWELL INDUSTRIES, INC.302551-200-01002022-03-15
00840067103159CadwellCADWELL INDUSTRIES, INC.302518-200-90002021-12-15
00840067103166CadwellCADWELL INDUSTRIES, INC.302519-200-00002021-12-15
00840067103180CadwellCADWELL INDUSTRIES, INC.302521-200-02002021-12-15
00840067103197CadwellCADWELL INDUSTRIES, INC.302521-200-04002021-12-15
00840067103227CadwellCADWELL INDUSTRIES, INC.302526-200-02322021-12-15
00840067103241CadwellCADWELL INDUSTRIES, INC.302536-200-00802021-12-15
00840067103272CadwellCADWELL INDUSTRIES, INC.302548-200-02802021-12-15
00840067103289CadwellCADWELL INDUSTRIES, INC.302548-200-10362021-12-15
00840067103319CadwellCADWELL INDUSTRIES, INC.302550-200-00002021-12-15
00840067103326CadwellCADWELL INDUSTRIES, INC.302552-200-00002021-12-15
00840067103340CadwellCADWELL INDUSTRIES, INC.302555-200-10242021-12-15
00840067103357CadwellCADWELL INDUSTRIES, INC.302556-200-00802021-12-15
00840067103364CadwellCADWELL INDUSTRIES, INC.302556-200-90802021-12-15
00840067103449CadwellCADWELL INDUSTRIES, INC.302570-200-00002021-12-15
00840067103647CadwellCADWELL INDUSTRIES, INC.302513-200-00002021-12-15
00840067103654CadwellCADWELL INDUSTRIES, INC.302523-200-01002021-12-15
00840067103661CadwellCADWELL INDUSTRIES, INC.302523-200-03002021-12-15
00840067103708CadwellCADWELL INDUSTRIES, INC.302510-200-14802021-12-15
00840067103739CadwellCADWELL INDUSTRIES, INC.302515-200-94802021-12-15
00840067103746CadwellCADWELL INDUSTRIES, INC.302516-200-02802021-12-15
00840067103784CadwellCADWELL INDUSTRIES, INC.302524-200-04002021-12-15
00840067103814CadwellCADWELL INDUSTRIES, INC.302530-200-00802021-12-15
00840067103845CadwellCADWELL INDUSTRIES, INC.302510-200-02802021-12-15
00840067103876CadwellCADWELL INDUSTRIES, INC.302532-200-00802021-12-15
10190752161122LTVVYAIRE MEDICAL, INC.116262021-03-12
10190752161993SOMNOSTARVYAIRE MEDICAL, INC.28008-0012021-03-12
10190752167629AveaVYAIRE MEDICAL, INC.24-773170-1022021-03-12
10190752173545LTVVYAIRE MEDICAL, INC.4666312021-03-12
00606959054677DreamStationRespironics, Inc.002021-02-04
00606959060388ALICE PDX Assembly, DOMRespironics, Inc.DOMESTIC2020-12-15
00606959060395ALICE PDX Assembly, INTLRespironics, Inc.INTERNATIONAL2020-12-15
00606959060401Alice PDX Assembly, JPRespironics, Inc.JAPAN2020-12-15
00606959060418ALICE PDX Assembly, BRRespironics, Inc.BRAZIL2020-12-15
05430001742039NightOwlEctosenseMini2020-06-30
00860512000215AccuSomNOVASOM, INC.NS20102020-02-21
00860512000222AccuSomNOVASOM, INC.NS20102020-03-03
00860512000239AccuSomNOVASOM, INC.NS20102020-03-03
00860512000246AccuSomNOVASOM, INC.NS20102020-03-03
B406CAT024030MATRx PlusZephyr Sleep Technologies IncMATRx plus CAT-024-032019-10-31
B406CAT024020MATRx plusZephyr Sleep Technologies IncMATRx plus CAT-024-022019-05-16
00817111021141Nomad PMU800 Portable Recorder (USB)Neurotronics, LLCPMU8002019-05-01
B406CAT024010MATRx plusZephyr Sleep Technologies IncMATRx plus CAT-024-012018-10-30
04250413404094SOMNOtouch RESP accessorySOMNOmedics AGTOS0202016-09-19
04250413404612SOMNOtouch RESPSOMNOmedics AGTOR050U2016-09-18
00851113007307Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.SP29-10102016-09-24
00851113007314Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.SP29-10112016-09-24
00851113007321Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.SP29-10122016-09-24
00854485007005ARES 620 UnicorderWatermark Medical, Inc.6202017-05-19
00854485007050ARES620 Respiration Module AssemblyWatermark Medical, Inc.6202017-05-19
00854485007067ARES620 Respiration Adapter AssemblyWatermark Medical, Inc.6202017-05-19
00854485007074ARES620 Respiration Belt AssemblyWatermark Medical, Inc.6202017-05-19
00854485007081ARES 610 UnicorderWatermark Medical, Inc.6102017-05-19
00854485007128ARES Secure Sleep Study AccessoriesWatermark Medical, Inc.610/6202017-05-19
00854485007135ARES Secure Sleep Study Disposable Kit - 10 packWatermark Medical, Inc.610/6202017-05-19
00854485007142ARES COC CableWatermark Medical, Inc.610/6202017-05-19
00854485007159ARES COC DongleWatermark Medical, Inc.610/6202017-05-19
00854485007166ARES620 Respiration Adapter CableWatermark Medical, Inc.6202017-05-19
00854485007173ARES 620 Respiration Effort SystemWatermark Medical, Inc.6202017-08-07
00854485007180ARES 620 Respiration Effort Disposables Kit - 10 packWatermark Medical, Inc.6202017-08-07
00860512000208AccuSomNOVASOM, INC.NS20102016-11-30
00817111020762Nomad PMU800 Portable RecorderNeurotronics, LLCPMU8002016-09-22