The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Adult Reusable Sp02 Sensor, Model M1191b, M1191bl, M1191bnl.
| Device ID | K062455 |
| 510k Number | K062455 |
| Device Name: | PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL |
| Classification | Oximeter |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Rich Mccleary |
| Correspondent | Rich Mccleary PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-23 |
| Decision Date | 2006-11-03 |
| Summary: | summary |