The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Philips Sp02 Disposable Sensor, Model M1131a.
| Device ID | K042306 |
| 510k Number | K042306 |
| Device Name: | PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A |
| Classification | Oximeter |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Contact | Egon Pfeil |
| Correspondent | Egon Pfeil PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-25 |
| Decision Date | 2004-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884838010186 | K042306 | 000 |