The following data is part of a premarket notification filed by Tenacore Holdings, Inc. with the FDA for Tenacore Sp02 Sensors.
| Device ID | K053420 |
| 510k Number | K053420 |
| Device Name: | TENACORE SP02 SENSORS |
| Classification | Oximeter |
| Applicant | TENACORE HOLDINGS, INC. 647 EAST YOUNG ST. Santa Ana, CA 92705 |
| Contact | Brand Caso |
| Correspondent | Brand Caso TENACORE HOLDINGS, INC. 647 EAST YOUNG ST. Santa Ana, CA 92705 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-08 |
| Decision Date | 2006-11-15 |
| Summary: | summary |