FDA.report

Pulse oximeter

Definition
An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.
GUDID devices
325
Last updated
2026-03-24 18:17:00

Related Product Codes

CodeDeviceSpecialtyClassDevices
DQAOximeterCardiovascular2185
OCHOximeter, Infrared, Sporting, AviationCardiovascular2105
PGJOximeter, WellnessCardiovascular230
FLLContinuous Measurement ThermometerGeneral Hospital22
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular22
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology21
DQDStethoscope, ElectronicCardiovascular21
OLKPulse Oximeter For Over-The-Counter UseCardiovascular21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
06938395500253HomedicsShenzhen Hexin ZONDAN Medical Equipment Co., LtdPX-200L2026-03-13
08719481723408iProvènSevenground Trading B.V.OXI-27 black2026-03-09
00842135100053myMDI Finger Pulse OximeterMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDPO-FPO-US2017-04-13
06927394502771Accurate®Hunan Accurate Bio-Medical Technology Co., Ltd.WS20E2026-02-02
06942820462535BLUE JAYBeijing Choice Electronic Technology Co., Ltd.BJ2401052026-01-23
00850068074082TenoviTenovi Co.TE-CPOG-A12026-01-14
00850068074105TenoviTenovi Co.TE-BPOG-A12026-01-07
00817698020728HLSHEALTHCARE LOGISTICS SYSTEMS LLC13002026-01-06
04897087200609EMAYEMAY (HK) LIMITEDEMO-602022-12-15
04897087200906EMAYEMAY (HK) LIMITEDEMO-902022-12-15
06942820462511VIEW O2Beijing Choice Electronic Technology Co., Ltd.180-50572025-12-23
06942820462528OxywatchBeijing Choice Electronic Technology Co., Ltd.DSI-DSFP-22025-12-23
06973912940525 simplicare IMDKC101A22025-12-03
04897140630114Belun RingBelun Technology Company LimitedBLR-100X2025-11-13
00846841092527ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OxyWatch C292025-09-29
00846841092695ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.MD300CN568R2025-09-24
B635BIOKIT0100Biokit O2BIOTRICITY INCAOJ-70B2025-09-24
30845717010130Veridian HealthcareVERIDIAN HEALTHCARE LLC11-50Q12025-09-09
00845717011945R.P.M. PROVERIDIAN HEALTHCARE LLC210-3110B2025-09-08
00845717012164TrackstarVERIDIAN HEALTHCARE LLC302-1110B2025-09-08
06951740540360NOVAShenzhen Jumper Medical Equipment Co.,Ltd.PO-3012025-08-07
00846841091599mibestBeijing Choice Electronic Technology Co., Ltd.MD300C572025-07-22
00846841092565ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.MD300CI218R2025-07-22
00846841092701mibestBeijing Choice Electronic Technology Co., Ltd.MD300C562025-07-22
00846841092947ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.OxyWatch C2052025-07-22
00846841092954ChoiceMMedBeijing Choice Electronic Technology Co., Ltd.MD300CN550R2025-07-22
06942820462504ChoicemmedBeijing Choice Electronic Technology Co., Ltd. MD300W6282025-07-22
06921745201061YonkerXuzhou Yongkang Electronic Science Technology Co., LtdYK-81C2025-06-17
16921745201198BRAUNXuzhou Yongkang Electronic Science Technology Co., LtdBPX801US2025-06-17
06933257921948YUWELL®Finger Pulse OximeterJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.YX1022025-06-16
06933257921955YUWELL® Finger Pulse OximeterJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.YX1032025-06-16
06933257921993YUWELL® Finger Pulse OximeterJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.YX3062025-06-16
06951740520188JUMPERShenzhen Jumper Medical Equipment Co.,Ltd.JPD-100E12025-05-09
00817698020704Healthcare Logistics SystemsHEALTHCARE LOGISTICS SYSTEMS LLC15502025-05-01
00817698020711Healthcare Logistics SystemsHEALTHCARE LOGISTICS SYSTEMS LLC12502025-05-01
06942820462368ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300CI218R2025-04-27
06942820462375ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300CI216R2025-04-27
06942820462399ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C2282025-04-27
06942820462405ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C22025-04-27
06942820462412ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C212025-04-27
06942820462429ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C222025-04-27
06942820462436ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C232025-04-27
06942820462443ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C262025-04-27
06942820462450ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C292025-04-27
06942820462467ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C2032025-04-27
06942820462474ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C2082025-04-27
06942820462481ChoicemmedBeijing Choice Electronic Technology Co., Ltd.MD300C2982025-04-27
06942820462498ChoicemmedBeijing Choice Electronic Technology Co., Ltd.S108 Lite2025-04-27
00850000967014CMI HealthCMI HEALTH INC.PC-66L W412025-04-23
00850000967038CMI HealthCMI HEALTH INC.PC-66L2025-04-23
00850000967052CMI HealthCMI HEALTH INC.PC-66L W722025-04-23
10859020006397FDKFudakang Industrial Inc.FT-E688 Plus2025-04-14
00860004541752ANNE LimbSibel Health Inc.810-000132025-04-02
00850064210125ANNE Limb Adhesive Shelf BoxSibel Health Inc.900-000112025-03-27
00850064210088ANNE Limb Sensor KitSibel Health Inc.900-000032025-03-26
06934440102977LEPU MEDICALShenzhen Viatom Technology Co.,Ltd.PO22025-03-17
06934440103066Pulse OximeterShenzhen Viatom Technology Co.,Ltd.PO22025-03-17
06934440103073Pulse OximeterShenzhen Viatom Technology Co.,Ltd.PO2A2025-03-17
06934440103080Pulse OximeterShenzhen Viatom Technology Co.,Ltd.PO2B2025-03-17
00850063139274NEIL MEDICALNeil Medical GroupOX1002025-03-14
06951740520171JUMPERShenzhen Jumper Medical Equipment Co.,Ltd.JPD-100F2025-02-07
00850047602275Movano HealthMovano Inc.EvieMED Ring, Size 5, Silver2025-01-31
00850047602282Movano HealthMovano Inc.EvieMED Ring, Size 6, Silver2025-01-31
00850047602299Movano HealthMovano Inc.EvieMED Ring, Size 7, Silver2025-01-31
00850047602305Movano HealthMovano Inc.EvieMED Ring, Size 8, Silver2025-01-31
00850047602312Movano HealthMovano Inc.EvieMED Ring, Size 9, Silver2025-01-31
00850047602329Movano HealthMovano Inc.EvieMED Ring, Size 10, Silver2025-01-31
00850047602336Movano HealthMovano Inc.EvieMED Ring, Size 11, Silver2025-01-31
00850047602343Movano HealthMovano Inc.EvieMED Ring, Size 12, Silver2025-01-31
00850047602350Movano HealthMovano Inc.EvieMED Charger, Large sizes 9-112025-01-31
00850047602367Movano HealthMovano Inc.EvieMED Charger, Small sizes 5-82025-01-31
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00850043916031ZacurateEINSTEIN ASSOCIATES LLC500B-B2025-01-28
00851697006543InnovoEINSTEIN ASSOCIATES LLCiP900AP2025-01-28
00851697006659InnovoEINSTEIN ASSOCIATES LLCiP900BP-B2025-01-28
00856964007513ZacurateEINSTEIN ASSOCIATES LLC500CL2025-01-28
00856964007698ZacurateEINSTEIN ASSOCIATES LLC500DL Black2025-01-28
00856964007704ZacurateEINSTEIN ASSOCIATES LLC500DL Purple2025-01-28
00856964007728ZacurateEINSTEIN ASSOCIATES LLC500C Black2025-01-28