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 |
|---|---|---|---|
| Feb 21, 1997 | K964055 | FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) Epic Medical Equipment Services, Inc. | DQA |
| Feb 11, 1997 | K945290 | 8500A PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Feb 6, 1997 | K962603 | MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES Masimo Corp. | DQA |
| Dec 13, 1996 | K963707 | NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) Nellcor Puritan Bennett, Inc. | DQA |
| Dec 4, 1996 | K952315 | SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE Emg Scientific | DQA |
| Nov 26, 1996 | K963496 | OXI TEMP Bci Intl., Inc. | DQA |
| Oct 10, 1996 | K962127 | OHMEDA 3800 PULSE OXIMETER Ohmeda Medical | DQA |
| Sep 12, 1996 | K954168 | E100A PULSE OXIMETER FINGER SENSOR/PROBE Epic Medical Equipment Services, Inc. | DQA |
| Aug 28, 1996 | K962156 | 3304 PULSE OXIMETER Bci Intl., Inc. | DQA |
| Aug 1, 1996 | K961450 | SCORE SOFTWARE Nellcor Puritan Bennett, Inc. | DQA |
| Jun 5, 1996 | K960614 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) Somanetics Corp. | DQA |
| May 15, 1996 | K960058 | OXITEMP, 3301T SA Bci Intl., Inc. | DQA |
| May 3, 1996 | K954267 | BURDICK 200 PULSE OXIMETER Burdick, Inc. | DQA |
| Mar 26, 1996 | K960251 | COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR Aristo Medical Products, Inc. | DQA |
| Nov 29, 1995 | K940933 | 9267 SPO2 ATHENA MODULE S & W Medico Teknik, DK | DQA |
| Nov 22, 1995 | K953817 | ARISTO MEDICAL MODEL 2101 PATIENT MONITOR Aristo Medical Products, Inc. | DQA |
| Sep 21, 1995 | K953126 | OXILINK (SMALL, MEDIUM, LARGE) Bci Intl., Inc. | DQA |
| Aug 25, 1995 | K952327 | SMARTSAT PULSE OXIMETRY ANALYZER Clinical Dynamics Corp. | DQA |
| Aug 17, 1995 | K952316 | NELLCOR SYMPHONY N-3000 PULSE OXIMETER Nellcor, Inc. | DQA |
| Aug 15, 1995 | K952222 | NELLCOR N-20PA PORTABLE PULSE OXIMETER Nellcor, Inc. | DQA |
| Jul 17, 1995 | K945754 | NEWOX2 Bci Intl., Inc. | DQA |
| May 12, 1995 | K942347 | NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 Nellcor, Inc. | DQA |
| Mar 24, 1995 | K943842 | PULSE OXIMETER MODEL 305 Palco Laboratories, Inc. | DQA |
| Mar 17, 1995 | K946185 | 3301T OXITEMP Bci Intl., Inc. | DQA |
| Feb 16, 1995 | K942842 | HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE Hewlett-Packard GmbH, DE | DQA |
| Feb 1, 1995 | K945464 | FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE Fukuda Denshi USA, Inc. | DQA |
| Dec 8, 1994 | K942248 | MINIATURIZED FINGER CLIP PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Oct 18, 1994 | K943817 | MARQUETTE ADULT/NEONATAL WRAP SENSOR Marquette Electronics, Inc. | DQA |
| Oct 17, 1994 | K943456 | AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT Datex Division Instrumentarium Corp., FI | DQA |
| Oct 13, 1994 | K943404 | 3301 PULSE OXIMETER Bci Intl., Inc. | DQA |
| Oct 13, 1994 | K941351 | BURDICK PRO2 OXIMETER Burdick Corp. | DQA |
| Oct 4, 1994 | K944608 | HP M1722A/B AND M1723A/B CODEMASTER Hewlett-Packard Co. | DQA |
| Sep 29, 1994 | K931304 | OHMEDA HAND HELD OXIMETER Ohmeda Medical | DQA |
| Sep 1, 1994 | K933519 | INDEX SPO2 SIMULATOR Bio-Tek Instruments, Inc. | DQA |
| Aug 16, 1994 | K933755 | SENSOR SHIELD, MODIFICATION Medical Taping Systems, Inc. | DQA |
| Jul 19, 1994 | K932203 | VITALMAX 530 Pace Tech Medical Monitors, Inc. | DQA |
| Jul 1, 1994 | K935510 | VX4 RECORDING PULSE OXIMETER Vitalog Monitoring,Inc. | DQA |
| Jun 22, 1994 | K941289 | PULSE OXIMETER Bci Intl., Inc. | DQA |
| Apr 11, 1994 | K920083 | BIOCHEM MODEL 3302 NEWOX2 OXIMETER Biochem International, Inc. | DQA |
| Apr 1, 1994 | K921454 | FUKUDA DENSHI MODEL HG-301 Fukuda Denshi USA, Inc. | DQA |
| Mar 15, 1994 | K934091 | OXISAT Marquette Electronics, Inc. | DQA |
| Mar 14, 1994 | K940463 | NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS Nonin Medical, Inc. | DQA |
| Dec 3, 1993 | K924626 | NOVAMETRIX MODEL 510 Novametrix Medical Systems, Inc. | DQA |
| Sep 10, 1993 | K924752 | FREEDOM OXIMETER/EEG DIGITAL INTERFACE Pro-Tech, Inc. | DQA |
| Jul 16, 1993 | K920966 | SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) Aristo Medical Products, Inc. | DQA |
| May 27, 1993 | K915699 | NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 Nellcor, Inc. | DQA |
| May 11, 1993 | K924285 | MODEL 3500 MR-COMPATIBLE PULSE OXIMETER Magnetic Resonance Equipment Corp. | DQA |
| May 7, 1993 | K924282 | MODEL 320 MR-COMPATIBLE PULSE OXIMETER Magnetic Resonance Equipment Corp. | DQA |
| Mar 16, 1993 | K920066 | PALCO LABS MODEL 340 PULSE OXIMETER Palco Laboratories, Inc. | DQA |
| Feb 23, 1993 | K923418 | 9293/1 INTERFACE MODULE S & W Medico Teknik, DK | DQA |
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