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)
Top companies in DQA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 11, 2019 | K191420 | Reusable SpO2 Sensor Shenzhen Changke Connect Electronics Co., Ltd., CN | DQA |
| Oct 10, 2019 | K191417 | Belun Ring Belun Technology Company Limited, HK | DQA |
| Sep 13, 2019 | K190869 | Pulse Oximeter Shenzhen Aeon Technology Co., Ltd., CN | DQA |
| Aug 22, 2019 | K190792 | BB-613WP Biobeat Technologies , Ltd., IL | DQA |
| Aug 5, 2019 | K190399 | Beddr 200 System Hancock Medical, Inc. | DQA |
| Jun 25, 2019 | K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System Taiwan Aulisa Medical Devices Technologies, Inc., TW | DQA |
| May 15, 2019 | K183277 | SpO2 Sensor Shenzhen Upnmed Equipment Co., Ltd., CN | DQA |
| Mar 29, 2019 | K181352 | Loop System Spry Health, Inc. | DQA |
| Mar 22, 2019 | K182887 | Masimo Rad-67 Pulse CO-Oximeter and Accessories Masimo Corporation | DQA |
| Mar 22, 2019 | K181738 | Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors Surgical Instrument Service and Savings Inc (Dba Medline | DQA |
| Mar 1, 2019 | K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System Taiwan Aulisa Medical Devices Technologies, Inc., TW | DQA |
| Mar 1, 2019 | K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System Taiwan Aulisa Medical Devices Technologies, Inc., TW | DQA |
| Feb 15, 2019 | K183556 | oCare Wrist Pulse Oximeter Taiwan Biophotonic Corporation, TW | DQA |
| Jan 23, 2019 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter Masimo Corporation | DQA |
| Dec 21, 2018 | K180380 | vital signs monitor Edan Instruments, Inc., CN | DQA |
| Nov 29, 2018 | K180685 | AS-3XX Series Fingertip Pulse Oximeter Xiamen Acurio Instruments Co., Ltd., CN | DQA |
| Nov 13, 2018 | K172792 | Handheld Pulse Oximeter, Model SP-20 Shenzhen Creative Industry Co., Ltd., CN | DQA |
| Oct 23, 2018 | K180046 | Masimo Rad-97 and Accessories Masimo Corporation | DQA |
| Oct 11, 2018 | K181503 | Fingertip Pulse Oximeter Beijing Choice Electronic Technology Co., Ltd., CN | DQA |
| Sep 21, 2018 | K181006 | BB-613 Watch Oximeter Bio-Beat Technologies , Ltd., IL | DQA |
| Sep 7, 2018 | K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors Orantech, Inc., CN | DQA |
| Aug 31, 2018 | K173368 | Reusable & Disposable SpO2 Sensors Shenzhen Coreray Technology, Ltd., CN | DQA |
| Aug 17, 2018 | K172492 | Optical Topography System ETG-4100 Hitachi Healthcare Americas | DQA |
| Aug 13, 2018 | K173123 | Pulse Oximeter Shenzhen Imdk Medical Technology Co., Ltd., CN | DQA |
| Jul 27, 2018 | K172616 | Pulse Oximeter Beijing Safe Heart Technology , Ltd., CN | DQA |
| Jun 8, 2018 | K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors APK Technology Co., Ltd., CN | DQA |
| Jun 5, 2018 | K173045 | Oximeter Shenzhen Greatmade Tech Limited, CN | DQA |
| May 29, 2018 | K180174 | Belun Ring Belun Technology Company Limited, HK | DQA |
| May 11, 2018 | K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor Nonin Medical, Inc. | DQA |
| Apr 4, 2018 | K172141 | Pulse Oximeter Shanghai Berry Electronic Tech Co., Ltd., CN | DQA |
| Mar 27, 2018 | K171241 | Pulse Oximeter Hunan Accurate Bio-Medical Technology Co., Ltd., CN | DQA |
| Mar 16, 2018 | K172366 | Wrist Pulse Oximeter Beijing Choice Electronic Technology Co., Ltd., CN | DQA |
| Dec 15, 2017 | K172482 | The Nellcor pulse oximetry monitor interface cable Covidien | DQA |
| Nov 3, 2017 | K170965 | Fingertip Pulse Oximeter Shenzhen Jumper Medical Equipment Co., Ltd., CN | DQA |
| Sep 19, 2017 | K163135 | Finger Pulse Oximeter Shenzhen Fitfaith Technology Co.,Ltd, CN | DQA |
| Jul 27, 2017 | K171423 | Nasal Alar SpO2 Sensor Xhale, Inc. | DQA |
| May 9, 2017 | K163382 | Oxitone 1000 Oxitone Medical , Ltd., IL | DQA |
| May 8, 2017 | K161938 | Fingertip Pulse Oximeter Xuzhou Yongkang Electronic Science Technology Co., Ltd., CN | DQA |
| Mar 3, 2017 | K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring System Taiwan Aulisa Medical Devices Technologies, Inc., TW | DQA |
| Feb 6, 2017 | K162014 | Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor Bluepoint Medical GmbH & Co. KG, DE | DQA |
| Jan 4, 2017 | K153184 | Caremed Reusable & Disposable SPO2 Sensors Shenzhen Caremed Medical Technology Co., Ltd., CN | DQA |
| Dec 28, 2016 | K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter Masimo Corporation | DQA |
| Dec 23, 2016 | K160231 | Model X-100C CO-Met Oximetry System Nonin Medical, Inc. | DQA |
| Nov 23, 2016 | K160940 | Masimo Disposable Transflectance Forehead Sensor Masimo Corporation | DQA |
| Nov 22, 2016 | K153021 | Fingertip Pulse Oximeter A310 Amemo, Inc. | DQA |
| Oct 14, 2016 | K160268 | Fingertip Pulse Oximeter MD300CG11/MD300CG51 Beijing Choice Electronic Technology Co., Ltd., CN | DQA |
| Oct 5, 2016 | K161560 | Fingertip Pulse Oximeter MD300CN310 Beijing Choice Electronic Technology Co., Ltd., CN | DQA |
| Sep 2, 2016 | K160582 | WiCap Athena Gtx | DQA |
| Aug 18, 2016 | K152390 | Medke Oximetry Finger Sensor Shenzhen Medke Technology Co., Ltd., CN | DQA |
| Aug 18, 2016 | K152091 | Fingertip Pulse Oximeter Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd., CN | DQA |
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