Panels › Cardiovascular › Product code DPZ · Class 2
Oximeter, Ear
Regulation 870.2710
0510(k)s in 12 months (11 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DPZ
| Company | 510(k)s | Recalls |
|---|---|---|
| GE Healthcare Finland Oy | 0 | 9 |
| Datex-Ohmeda, Inc. | 1 | 1 |
| Epic Medical Equipment Services, Inc. | 2 | 0 |
| GE Healthcare, LLC | 0 | 2 |
| Bio-Tek Instruments, Inc. | 1 | 0 |
| Draeger Medical, Inc. | 1 | 0 |
| Elekon Industries U.S.A., Inc. | 1 | 0 |
| Fitness Quest, Inc. | 1 | 0 |
| Marquette Electronics, Inc. | 1 | 0 |
| Nellcor, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 6, 2004 | K042675 | FLEXI-STAT SP02 EAR SENSOR Elekon Industries U.S.A., Inc. | DPZ |
| Sep 2, 2004 | K040831 | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 Datex-Ohmeda, Inc. | DPZ |
| Oct 17, 2001 | K012333 | FLEXI-SITE SP02 EAR SENSOR Epic Medical Equipment Services, Inc. | DPZ |
| Mar 23, 2001 | K010718 | FLEXI-SITE SP02 EAR SENSOR Epic Medical Equipment Services, Inc. | DPZ |
| Oct 17, 1994 | K944760 | DURA-Y OXYGEN TRANSDUCER, EAR CLIP Nellcor, Inc. | DPZ |
| Sep 2, 1994 | K942752 | MARQUETTE EAR PROBE SENSOR Marquette Electronics, Inc. | DPZ |
| Jan 31, 1992 | K914595 | PULSE RATE MONITOR Fitness Quest, Inc. | DPZ |
| Sep 11, 1986 | K862426 | PULSE OXIMETER Draeger Medical, Inc. | DPZ |
| May 15, 1985 | K845051 | VITALOG PMS-8 Vitalog Corp. | DPZ |
| Mar 28, 1985 | K850494 | OHMEDA BIOX 3700 PULSE OXIMETER Ohmeda Medical | DPZ |
| Feb 27, 1981 | K810363 | EAR OXIMETER Bio-Tek Instruments, Inc. | DPZ |
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