The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Spo2 Reusable Sensor, Models M1196a And M1196t.
| Device ID | K062605 |
| 510k Number | K062605 |
| Device Name: | PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T |
| Classification | Oximeter |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Rich Mccleary |
| Correspondent | Rich Mccleary PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2006-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838025592 | K062605 | 000 |
| 00884838001398 | K062605 | 000 |
| 00884838001381 | K062605 | 000 |
| 00884838102569 | K062605 | 000 |