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)
Get daily alerts for DQASample briefCSV

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
Aug 17, 2016K152089Wrist Pulse Oximeter
Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd., CN
DQA
Aug 5, 2016K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN),
Nonin Medical, Inc.
DQA
Apr 18, 2016K152563Pulse Oximeter (MD300M/MD300K2)
Beijing Choice Electronic Technology Co., Ltd., CN
DQA
Mar 2, 2016K151024Finger Type Pulse Oximeter
Taidoc Technology Corporation, TW
DQA
Jan 6, 2016K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
Guangdong Biolight Meditech Co., Ltd., CN
DQA
Oct 22, 2015K150314Masimo MightySat Rx Fingertip Pulse Oximeter
Masimo Corporation
DQA
Aug 28, 2015K151206Fingertip Pulse Oximeter
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Jun 3, 2015K150093Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC
Shenzhen Creative Industry Co., Ltd., CN
DQA
Apr 23, 2015K141362PULSE OXIMETER CMS50EW
Contec Medical Systems Co.,Ltd, CN
DQA
Apr 13, 2015K142687Pulse Oximeter
Shanghai Berry Electronic Tech Co., Ltd., CN
DQA
Mar 26, 2015K142865Nellcor Bedside SpO2 Patient Monitoring System
Covidien, LLC
DQA
Mar 20, 2015K142959Vyntus Walk
Carefusion Germany 234 GmbH, DE
DQA
Mar 17, 2015K143216Assurance Alar / Nasal SpO2 Sensor
Xhale, Inc.
DQA
Mar 5, 2015K141518Nellcor Bedside Respiratory Patient Monitoring System
Covidien
DQA
Feb 20, 2015K142888Fingertip Pulse Oximeter
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Feb 6, 2015K142832Unimed Disposable and Reusable SPO2 Sensors
Unimed Medical Supplies, Inc., CN
DQA
Jan 16, 2015K142209Pulse oximeter NBM-200
Orsense, Ltd., IL
DQA
Jan 13, 2015K141024EXTERNAL PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Dec 4, 2014K141105PULSE OXIMETER
Hunan Accurate Bio-Medical Technology Co., Ltd., CN
DQA
Oct 2, 2014K141542NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
Covidien, LLC
DQA
Aug 28, 2014K140582FINGERTIP PULSE OXIMETER
Shenzhen Jumper Medical Equipment Co., Ltd., CN
DQA
Aug 13, 2014K141128FINGERTIP PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Jul 30, 2014K132516OXIPROBE E (OXIPROBE)
Bio Medical Technologies Co., Ltd.
DQA
Jul 17, 2014K140682FINGERTIP PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Jul 7, 2014K140785PULSE OXIMETER
Nonin Medical, Inc.
DQA
May 2, 2014K133064MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
Envitec-Wismar GmbH
DQA
Feb 28, 2014K133090OXICARE FINGERTIP PULSE OXIMETER
Delbio Incorporation
DQA
Feb 21, 2014K132402SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
Nonin Medical, Inc.
DQA
Feb 4, 2014K130320BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
Covidien
DQA
Oct 17, 2013K124041NBM-200MP
Orsense, Ltd.
DQA
Oct 16, 2013K131047FINGERTIP PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Oct 3, 2013K130947FINGERTIP PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Sep 27, 2013K132696TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
GE Healthcare Finland Oy
DQA
Sep 11, 2013K131111IHEALTH FINGERTIP PULSE OXIMETER
Andon Health Co, Ltd., CN
DQA
Sep 11, 2013K131021PULSE OXIMETER
Nonin Medical, Inc.
DQA
Aug 30, 2013K131818VITAL SIGNS MONITOR
Edan Instruments, Inc., CN
DQA
Aug 27, 2013K123797NT1D VITAL SIGNS MONITOR
New Tech, Inc., CN
DQA
May 28, 2013K123801FINGER PULSE OXIMETER
Shenzhen Kingyield Technology Co., Ltd., CN
DQA
May 10, 2013K123871FINGERTIP PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
May 9, 2013K123581NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
Covidien, Formerly Nellcor Puritan Bennett, Inc.
DQA
Apr 26, 2013K120984MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
Masimo Corporation
DQA
Apr 10, 2013K122996ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085
Xhale
DQA
Mar 21, 2013K113727SHENZHEN MED-LINK PULSE OXIMETER PROBE
Shenzhen Med-Link Electronics Tech Co., Ltd.
DQA
Feb 4, 2013K122046WRIST PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Dec 20, 2012K122927OXICARE FINGERTIP PULSE OXIMETER
Delbio Incorporated, TW
DQA
Dec 7, 2012K120502PC-60NW FINGERTIP OXIMETER
Shenzhen Creative Industry Co., Ltd.
DQA
Oct 15, 2012K121697FINGERTIP PULSE OXIMETER
Andon Health Co, Ltd., CN
DQA
Sep 28, 2012K121806BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
Covidien
DQA
Sep 19, 2012K120657MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
Masimo Corporation
DQA
Sep 7, 2012K121914MASIMO SET USPO2 PULSE OXIMETRY CABLE
Masimo Corporation
DQA

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.