The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Reusable Spo2 Sensors M1191t, M1192t And M1193t, Clip Sensor M1196t And Disposable Spo2 Sensors M1131a, M1132a.
| Device ID | K063783 |
| 510k Number | K063783 |
| Device Name: | PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A |
| Classification | Oximeter |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Tapan D Shah |
| Correspondent | Tapan D Shah PHILIPS MEDICAL SYSTEMS, INC. 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 | 2006-12-21 |
| Decision Date | 2007-04-27 |
| Summary: | summary |