The following data is part of a premarket notification filed by Sentinel Monitoring Technologies, Ltd. with the FDA for Sentinel Pulse Oximeter.
| Device ID | K880672 |
| 510k Number | K880672 |
| Device Name: | SENTINEL PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | SENTINEL MONITORING TECHNOLOGIES, LTD. 8765 GUION RD. SUITE E Indianapolis, IN 46268 |
| Contact | Jerry W Jarrard |
| Correspondent | Jerry W Jarrard SENTINEL MONITORING TECHNOLOGIES, LTD. 8765 GUION RD. SUITE E Indianapolis, IN 46268 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-19 |
| Decision Date | 1988-05-06 |