Product code DPZ
- Device name
- Oximeter, Ear
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2710
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042675 | FLEXI-STAT SP02 EAR SENSOR | Elekon Industries U.S.A., Inc. | 2004-12-06 |
| K040831 | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 | Datex-Ohmeda, Inc. | 2004-09-02 |
| K012333 | FLEXI-SITE SP02 EAR SENSOR | Epic Medical Equipment Services, Inc. | 2001-10-17 |
| K010718 | FLEXI-SITE SP02 EAR SENSOR | Epic Medical Equipment Services, Inc. | 2001-03-23 |
| K944760 | DURA-Y OXYGEN TRANSDUCER, EAR CLIP | Nellcor, Inc. | 1994-10-17 |
| K942752 | MARQUETTE EAR PROBE SENSOR | Marquette Electronics, Inc. | 1994-09-02 |
| K914595 | PULSE RATE MONITOR | Fitness Quest, Inc. | 1992-01-31 |
| K862426 | PULSE OXIMETER | Draeger Medical, Inc. | 1986-09-11 |
| K845051 | VITALOG PMS-8 | Vitalog Corp. | 1985-05-15 |
| K850494 | OHMEDA BIOX 3700 PULSE OXIMETER | Ohmeda Medical | 1985-03-28 |
| K810363 | EAR OXIMETER | Bio-Tek Instruments, Inc. | 1981-02-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195278949769 | TruSignal SpO2 MM 1.8M | GE Healthcare Finland Oy | 2026-10-04 |
| 00198953002186 | Carescape Dock F0 | GE Healthcare Finland Oy | 2026-10-04 |
| 00195278949752 | TruSignal SpO2 MM 3.0M | GE Healthcare Finland Oy | 2026-10-04 |
| 00198953009567 | Carescape ONE | GE Healthcare Finland Oy | 2026-10-04 |
| 07640121880971 | Patient Application Kit for sensitive/fragile skin | SenTec AG | 2021-09-26 |
| 07640121880964 | Patient Application Kit for mature intact skin | SenTec AG | 2021-09-26 |
| 07640121880889 | SDM Water Protection Cover | SenTec AG | 2021-08-25 |
| 07640121880902 | Isolation Transformer 100-120V | SenTec AG | 2021-05-05 |
| 07640121880810 | Ear Clip easy | SenTec AG | 2020-03-31 |
| 07640121880858 | Contact Gel 2ml | SenTec AG | 2019-03-08 |
| 07640121880803 | Multi-Site Attachment Ring for fragile/sensitive skin | SenTec AG | 2019-01-29 |
| 07640121880797 | Multi-Site Attachment Ring for mature/intact skin | SenTec AG | 2019-01-29 |
| 07640121880315 | PSG-X | SenTec AG | 2018-11-12 |
| 07640121880766 | PSG Cable P | SenTec AG | 2018-11-12 |
| 07640121880735 | PSG Cable N | SenTec AG | 2018-11-12 |
| 07640121880728 | PSG Cable M | SenTec AG | 2018-11-12 |
| 07640121880711 | PSG Cable L | SenTec AG | 2018-11-12 |
| 07640121880704 | PSG Cable K | SenTec AG | 2018-11-12 |
| 07640121880698 | PSG Cable J | SenTec AG | 2018-11-12 |
| 07640121880681 | PSG Cable H | SenTec AG | 2018-11-12 |
| 07640121880674 | PSG Cable G | SenTec AG | 2018-11-12 |
| 07640121880667 | PSG Cable F | SenTec AG | 2018-11-12 |
| 07640121880650 | PSG Cable E | SenTec AG | 2018-11-12 |
| 07640121880643 | PSG Cable D | SenTec AG | 2018-11-12 |
| 07640121880636 | PSG Cable C | SenTec AG | 2018-11-12 |
| 07640121880629 | PSG Cable B | SenTec AG | 2018-11-12 |
| 07640121880612 | PSG Cable A | SenTec AG | 2018-11-12 |
| 05700699058669 | Electrolyte 54 | Radiometer Medical ApS | 2016-09-01 |
| 05700699058683 | Membraning kit for tc sensor 54 | Radiometer Medical ApS | 2016-09-01 |
| 07640121880094 | Standard Starter Set | SenTec AG | 2016-08-31 |