ClearanceBrief
Panels › Cardiovascular › Product code DQA · Class 2

Oximeter

Regulation 870.2700

13510(k)s in 12 months (727 all time)
9recalls in 12 months (128 all time)
101recalls that name a 510(k)
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Top companies in DQA

Company510(k)sRecalls
Masimo Corp.7714
Nonin Medical, Inc.423
Oridion Medical 1987 , Ltd.132
Philips Healthcare Inc.025
Nellcor Puritan Bennett, Inc.194
Beijing Choice Electronic Technololgy Co., Ltd.210
Philips Medical Systems85
Covidien102
Dolphin Medical, Inc.120
Bci Intl., Inc.110
Decided510(k)Device and applicantCode
Dec 30, 2022K222010Biobeat Platform-2 and BB-613WP Patch
Biobeat Technologies , Ltd., IL
DQA
Dec 30, 2022K213430Fingertip Pulse Oximeter
Shenzhen Witleaf Medical Electronics Co., Ltd., CN
DQA
Dec 19, 2022K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
Unimed Medical Supplies, Inc., CN
DQA
Dec 16, 2022K213984Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)
Shenzhen Zhengkang Technology Co., Ltd., CN
DQA
Nov 20, 2022K221282Empatica Health Monitoring Platform
Empatica S.r.l., IT
DQA
Nov 18, 2022K220351Polso Watch
Chronisense Medical, Ltd., IL
DQA
Nov 8, 2022K203812Oxyfit Pulse Oximeter
Shenzhen Viatom Technology Co., Ltd., CN
DQA
Oct 16, 2022K221979Pulse Oximeter (Model C101A2, C101B1, C101A3)
Shenzhen Imdk Medical Technology Co., Ltd., CN
DQA
Aug 16, 2022K212385YUWELL Finger Pulse Oximeter
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
DQA
Aug 4, 2022K221953Masimo CARESCAPE SpO2 – Masimo with SpHb
Masimo Corporation
DQA
Jun 22, 2022K212665Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911
Huizhou Xiaoou Technology Co., Ltd., CN
DQA
Jun 12, 2022K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Technologies, Inc., TW
DQA
Jun 10, 2022K213515WesperO2
Wesper, Inc.
DQA
May 20, 2022K212752Med-link Pulse Oximeter
Shenzhen Med-Link Electronics Tech Co., Ltd., CN
DQA
May 6, 2022K212555Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
Covidien, LLC
DQA
Mar 25, 2022K212153Biobeat Platform, BB-613WP Patch
Biobeat Technologies , Ltd., IL
DQA
Mar 8, 2022K211140Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Trans
Stryker Sustainability Solutions
DQA
Feb 25, 2022K212300Pulse Oximeter
Shenzhen Mericonn Technology Co., Ltd., CN
DQA
Feb 11, 2022K211400Pulse Oximeter
Beijing Choice Electronic Technology Co., Ltd., CN
DQA
Jan 14, 2022K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
Shenzhen Narig Bio-Medical Technology Co., Ltd., CN
DQA
Dec 22, 2021K210305Pulse Oximeter
Dongguan Lingxin Technologies Co., Ltd., CN
DQA
Oct 21, 2021K211407Belun Ring BLR-100X
Belun Technology Company Limited, CN
DQA
Oct 8, 2021K212876Carescape SpO2 - Masimo
Masimo Corporation
DQA
Sep 1, 2021K210032Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
Leadtek Research, Inc., TW
DQA
Jul 30, 2021K210274Fingertip Pulse Oximeter
Zhuhai Linte Medical Instrument Co., Ltd., CN
DQA
Jul 23, 2021K201887VS Newborn Heart Rate Monitor
Surepulse Medical Limited, GB
DQA
Apr 23, 2021K203854Pulse Oximeter
Shenzhen Hexin Zondan Medical Equipment Co., Ltd., CN
DQA
Mar 1, 2021K202776Fingertip pulse oximeter
Shenzhen Lepu Intelligent Medical Equipment Co., Ltd., CN
DQA
Mar 1, 2021K202743Med-Link Temp-pulse Oximeter
Shenzhen Med-Link Electronics Tech Co., Ltd., CN
DQA
Jan 25, 2021K201468Pulse Oximeter
Shenzhen Creative Industry Co., Ltd., CN
DQA
Dec 14, 2020K202324Fingertip Pulse Oximeter
Shenzhen Bsx Technology Electronics Co., Ltd., CN
DQA
Dec 7, 2020K202173Pulse Oximeter
Shenzhen AOJ Medical Technology Co., Ltd., CN
DQA
Dec 7, 2020K201384Pulse Oximeter
Shenzhen Raysintone Technology Co., Ltd., CN
DQA
Nov 27, 2020K202851Spo2 Sensor
Jkh USA, LLC
DQA
Nov 27, 2020K201294Pulse Oximeter
Guangdong Long Yao Electronic Technology Co., Ltd., CN
DQA
Sep 24, 2020K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
Masimo Corporation
DQA
Sep 23, 2020K200414Pulse Oximeter
Shenzhen Aeon Technology Co., Ltd., CN
DQA
Aug 19, 2020K201360Reusable and Disposable SpO2 Sensors
Xinkang Medical Instrument Co. , Ltd., CN
DQA
Jul 20, 2020K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
Covidien, LLC
DQA
Jul 3, 2020K200537Oxxiom
True Wearables, Inc.
DQA
Jun 29, 2020K192900H500 Multi-Sensing Oximetry System
Nonin Medical, Inc.
DQA
Apr 27, 2020K193350Leadtek Fingertip Pulse Oximeter
Leadtek Research, Inc., TW
DQA
Apr 9, 2020K191574OxSAT 100
S.L.P. , Ltd., IL
DQA
Mar 13, 2020K200069Disposable SpO2 Sensor
Shenzhen Changke Connect Electronics Co., Ltd., CN
DQA
Jan 24, 2020K192608Disposable SpO2 Sensor
Shenzhen Sino-K Medical Technology Co.,Ltd, CN
DQA
Dec 31, 2019K192343Patient Monitor
Shenzhen Creative Industry Co., Ltd., CN
DQA
Dec 20, 2019K191403Pulse Oximeter
Nonin Medical, Inc.
DQA
Dec 6, 2019K191279Disposable SpO2 Sensor
Shenzhen Caremed Medical Technology Co., Ltd., CN
DQA
Dec 2, 2019K191088Checkme O2 Pulse Oximeter
Shenzhen Viatom Technology Co., Ltd., CN
DQA
Oct 18, 2019K191430Pulse Oximeter
Shenzhen Yimi Life-Technology Co., Ltd., CN
DQA

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