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 |
|---|---|---|---|
| Sep 4, 2012 | K120052 | CVINSIGHT Intelomed, Inc. | DQA |
| Jul 24, 2012 | K121912 | E1 EAR SENSORS Masimo Corporation | DQA |
| Jul 10, 2012 | K120773 | NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM Covidien, LLC | DQA |
| Apr 19, 2012 | K112843 | PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Mar 21, 2012 | K113865 | PULTOL Sharp Corporation | DQA |
| Feb 24, 2012 | K113596 | MASIMO SET REUSABLE OXIMETRY SENSORS Masimo Corporation | DQA |
| Jan 27, 2012 | K112804 | FINGERTIP PULSE OXIMETER Guangdong Biolight Meditech Co., Ltd., CN | DQA |
| Jan 18, 2012 | K111494 | HANDHELD PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd., CN | DQA |
| Dec 30, 2011 | K111403 | MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES Masimo Corporation | DQA |
| Dec 22, 2011 | K111617 | PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 Acare Technology Co., Ltd., CN | DQA |
| Nov 22, 2011 | K110893 | VTRUST FINGER TYPE PULSE OXIMETER Taidoc Technology Corporation, TW | DQA |
| Oct 26, 2011 | K111621 | MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS Masimo Corporation | DQA |
| Sep 23, 2011 | K111888 | MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS Masimo Corporation | DQA |
| Sep 14, 2011 | K112465 | VITAL SIGNS MONITOR Advanced Instruments, Inc. | DQA |
| Aug 2, 2011 | K103802 | TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR GE Healthcare Finland Oy, FI | DQA |
| Jul 25, 2011 | K103285 | DIXTAL DZ-4100 SERIES PULSE OXIMETER Dixtal Medical, Inc. | DQA |
| Jul 15, 2011 | K103685 | PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA Beijing Rongrui-Century Scie. & Tech. Co., Ltd., CN | DQA |
| Jun 10, 2011 | K103584 | ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS Shenzhen Envisen Industry Co. Limited | DQA |
| Mar 17, 2011 | K110028 | MASIMO RADICAL Y PULSE CO-OXIMETER Masimo Corporation | DQA |
| Mar 15, 2011 | K103700 | ESSENTIAL MRI PATIENT MONITOR Invivo Corporation | DQA |
| Feb 22, 2011 | K102270 | ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN Envitec-Wismar GmbH | DQA |
| Feb 9, 2011 | K100225 | PULSE OXIMETER MODEL P10 Mediana Co., Ltd. | DQA |
| Jan 11, 2011 | K101995 | CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD Oridion Capnography, Inc. | DQA |
| Dec 27, 2010 | K102835 | VITAL SIGNS MONITOR Edan Instruments, Inc. | DQA |
| Dec 22, 2010 | K102350 | PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Dec 15, 2010 | K101012 | V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 Taidoc Technology Corporation, TW | DQA |
| Dec 2, 2010 | K101577 | MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES Beijing Choice Electronic Technololgy Co., Ltd., CN | DQA |
| Nov 24, 2010 | K101539 | VITAL SIGNS MONITOR MODEL M3B Edan Instruments, Inc., CN | DQA |
| Nov 18, 2010 | K101031 | MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 Masimo Corporation | DQA |
| Oct 21, 2010 | K101896 | MASIMO LNCS/M-LNCS OXIMETRY SENSORS Masimo Corporation | DQA |
| Oct 21, 2010 | K092641 | CHARMCARE TABLETOP PULSE OXIMETER Charmcare Co., Ltd. | DQA |
| Oct 7, 2010 | K100077 | NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 Solaris Medical Technology, Inc. | DQA |
| Oct 4, 2010 | K101871 | TRUSIGNAL SPO2 FINGERTIP SENSOR GE Healthcare Finland Oy, FI | DQA |
| Sep 20, 2010 | K101568 | MODEL SB100II FINGER PULSE OXIMETER Atlantean | DQA |
| Sep 10, 2010 | K102442 | E.S.O. (ELECTRO SENSOR OXI) Ld Technology, LLC | DQA |
| Sep 8, 2010 | K101694 | HANDHELD PULSE OXIMETER MODEL M800 Guangdong Biolight Meditech Co., Ltd., CN | DQA |
| Aug 31, 2010 | K101600 | INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE | DQA |
| Jul 9, 2010 | K100428 | MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER Masimo Corporation | DQA |
| Jun 23, 2010 | K100403 | MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 Masimo Corporation | DQA |
| Jun 16, 2010 | K100815 | OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 Oxypulse | DQA |
| Jun 4, 2010 | K093853 | SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES Nonin Medical, Inc. | DQA |
| May 28, 2010 | K100617 | MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D Masimo Corporation | DQA |
| May 17, 2010 | K100203 | HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M Beijing Choice Electronic Technololgy Co., Ltd., CN | DQA |
| May 14, 2010 | K094046 | LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS Masimo Corporation | DQA |
| Mar 30, 2010 | K093016 | VITAL SIGNS MONITOR Shenzhen Creative Industry Co., Ltd. | DQA |
| Mar 19, 2010 | K091564 | NBM-200MP PULSE OXIMETRY DEVICE Orsense, Ltd., IL | DQA |
| Mar 12, 2010 | K093881 | TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR GE Healthcare Finland Oy, FI | DQA |
| Mar 12, 2010 | K092950 | SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES Solaris Medical Technology, Inc. | DQA |
| Mar 8, 2010 | K100020 | DX SERIES FINGER SENSOR Dixtal Medical, Inc. | DQA |
| Mar 4, 2010 | K093306 | SINGLE-PATIENT USE DISPOSABLE SENSOR Nonin Medical, Inc. | DQA |
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