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 |
|---|---|---|---|
| Mar 30, 2006 | K052693 | PM-50 PULSE OXIMETER Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | DQA |
| Mar 16, 2006 | K053477 | MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS Masimo Corporation | DQA |
| Jan 11, 2006 | K053130 | ONYX II FINGER PULSE OXIMETER, MODEL 9550 Nonin Medical, Inc. | DQA |
| Jan 10, 2006 | K051271 | OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR Nellcor Puritan Bennett, Inc. | DQA |
| Jan 6, 2006 | K052619 | THE FINGER GUARD T F & G Products | DQA |
| Dec 23, 2005 | K052669 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 Nonin Medical, Inc. | DQA |
| Dec 22, 2005 | K051257 | ADULT CEREBRAL OXIMETER, MODEL 2040 Cas Medical Systems, Inc. | DQA |
| Dec 21, 2005 | K053269 | MASIMO SET RAD-8 PULSE OXIMETER Masimo Corporation | DQA |
| Dec 2, 2005 | K051736 | FOX PULSE OXIMETER Shunsuke Nakanishi | DQA |
| Nov 17, 2005 | K052377 | PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. Philips Medizin Systeme Boeblingen GmbH, DE | DQA |
| Nov 10, 2005 | K052829 | WRISTOX MODEL 3100 PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Nov 10, 2005 | K052186 | NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P Nellcor Puritan Bennett, Inc. | DQA |
| Oct 13, 2005 | K052755 | DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT GE Healthcare | DQA |
| Aug 11, 2005 | K051352 | OXIMAX NPB-40 HANDHELD PULSE OXIMETER Nellcor Puritan Bennett, Inc. | DQA |
| Jul 15, 2005 | K051439 | LNOP BLUE OXIMETRY SENSOR Masimo Corporation | DQA |
| Jul 12, 2005 | K051212 | MODIFICATION TO LNCS OXIMETRY SENSORS Masimo Corporation | DQA |
| Jul 1, 2005 | K050018 | TESLAOXYSAT, MODEL EFOXYSATE Mammendorfer Institute For Physics & Medicine GmbH | DQA |
| Jun 23, 2005 | K050844 | 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL Cas Medical Systems, Inc. | DQA |
| Jun 21, 2005 | K050056 | MODEL 2500A PALMSAT PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Jun 1, 2005 | K051107 | ONYX II FINGER PULSE OXIMETER, MODEL 9550 Nonin Medical, Inc. | DQA |
| May 11, 2005 | K050252 | AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS Masimo Corporation | DQA |
| Feb 11, 2005 | K043463 | ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS Envitec-Wismar GmbH | DQA |
| Feb 9, 2005 | K050068 | LNOPV AD-L AND PD-L OXIMETRY SENSORS Masimo Corporation | DQA |
| Jan 19, 2005 | K042536 | MASIMO SET RAD 57 PULSE CO-OXIMETER Masimo Corporation | DQA |
| Jan 7, 2005 | K043359 | 4100 PATIENT OXIMETER MODULE Nonin Medical, Inc. | DQA |
| Dec 29, 2004 | K043162 | PMP4 OXY PRO Card Guard Scientific Survival , Ltd., IL | DQA |
| Dec 29, 2004 | K042705 | DISPOSABLE NON-ADHESIVE SPO2 SENSORS Elekon Industries U.S.A., Inc. | DQA |
| Nov 26, 2004 | K042704 | REUSABLE FINGER CLIP SPO2 SENSORS Elekon Industries U.S.A., Inc. | DQA |
| Oct 15, 2004 | K042306 | PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A Philips Medizin Systeme Boeblingen GmbH, DE | DQA |
| Oct 12, 2004 | K042501 | ETG-4000 OPTICAL TOPOGRAPHY SYSTEM Hitachi Medical Corp. | DQA |
| Sep 20, 2004 | K042346 | LNCS OXIMETRY SENSORS Masimo Corporation | DQA |
| Sep 14, 2004 | K041964 | MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS Mediaid, Inc. | DQA |
| Sep 14, 2004 | K041522 | FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS Elekon Industries U.S.A., Inc. | DQA |
| Sep 10, 2004 | K040178 | PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE S.P.O. Medical Equipment, Ltd., IL | DQA |
| Sep 2, 2004 | K041647 | FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) Elekon Industries U.S.A., Inc. | DQA |
| Aug 31, 2004 | K040380 | DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 Dolphin Medical, Inc. | DQA |
| Aug 31, 2004 | K032831 | PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 Conmed Corporation | DQA |
| Aug 26, 2004 | K032971 | TIDAL WAVE SP MODEL 710/715 AND 715 Respironics Novametrix, Inc. | DQA |
| Aug 23, 2004 | K032949 | SPOT CHECK PULSE OXIMETER,512/513 Respironics Novametrix, Inc. | DQA |
| Jul 29, 2004 | K041815 | LNCS OXIMETRY SENSORS Masimo Corp. | DQA |
| Jul 29, 2004 | K041644 | FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) Elekon Industries U.S.A., Inc. | DQA |
| Jul 19, 2004 | K041674 | THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT Philips Medical Systems | DQA |
| Jun 29, 2004 | K041204 | NC SP02 ADAPTER CABLE Masimo Corp. | DQA |
| Jun 9, 2004 | K041156 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 Nonin Medical, Inc. | DQA |
| Jun 3, 2004 | K040589 | MODIFICATION TO AVANT 9600 PULSE OXIMETER Nonin Medical, Inc. | DQA |
| May 27, 2004 | K040581 | MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM Vitel Net | DQA |
| May 21, 2004 | K032755 | MODEL 509M PULSE OXIMETER, MODEL 509M Respironics Novametrix, Inc. | DQA |
| May 6, 2004 | K033307 | NVISION DATA MANAGEMENT SOFTWARE Nonin Medical, Inc. | DQA |
| Apr 22, 2004 | K040259 | MASIMO SET INTELLIVUE PULSE OXIMETER MODULE Masimo Corp. | DQA |
| Mar 19, 2004 | K033998 | MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V Masimo Corp. | DQA |
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