The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Spo2 Reusable Sensors, Model Nos. M1191t, M1192t, And M1193t.
| Device ID | K032979 |
| 510k Number | K032979 |
| Device Name: | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T |
| Classification | Oximeter |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. HEWLETT PACKARD STR. 2 Boblingen, DE D71034 |
| Contact | Egon Pfeil |
| Correspondent | Egon Pfeil PHILIPS MEDICAL SYSTEMS, INC. HEWLETT PACKARD STR. 2 Boblingen, DE D71034 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-24 |
| Decision Date | 2004-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838011946 | K032979 | 000 |
| 00884838010277 | K032979 | 000 |
| 00884838010253 | K032979 | 000 |
| 00884838010239 | K032979 | 000 |