EAR OXIMETER
FDA 510(k) clearance K810363 · decided 1981-02-27
Clearance details
- K-number
- K810363
- Device name
- EAR OXIMETER
- Applicant
- Bio-Tek Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-11
- Decision date
- 1981-02-27
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- DPZ
- Device class
- 2
- Regulation number
- 870.2710
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FLEXI-STAT SP02 EAR SENSOR (K042675) | Elekon Industries U.S.A., Inc. | 2004-12-06 |
| DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (K040831) | Datex-Ohmeda, Inc. | 2004-09-02 |
| FLEXI-SITE SP02 EAR SENSOR (K012333) | Epic Medical Equipment Services, Inc. | 2001-10-17 |
| FLEXI-SITE SP02 EAR SENSOR (K010718) | Epic Medical Equipment Services, Inc. | 2001-03-23 |
| DURA-Y OXYGEN TRANSDUCER, EAR CLIP (K944760) | Nellcor, Inc. | 1994-10-17 |
| MARQUETTE EAR PROBE SENSOR (K942752) | Marquette Electronics, Inc. | 1994-09-02 |
| PULSE RATE MONITOR (K914595) | Fitness Quest, Inc. | 1992-01-31 |
| PULSE OXIMETER (K862426) | Draeger Medical, Inc. | 1986-09-11 |
| VITALOG PMS-8 (K845051) | Vitalog Corp. | 1985-05-15 |
| OHMEDA BIOX 3700 PULSE OXIMETER (K850494) | Ohmeda Medical | 1985-03-28 |
Recalls involving this device
No recalls on record reference this clearance.