The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Philips Disposable Spo2 Sensors Mii32a And M1133a..
| Device ID | K052377 |
| 510k Number | K052377 |
| Device Name: | PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. |
| 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 | 2005-08-30 |
| Decision Date | 2005-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884838010209 | K052377 | 000 |
| 30884838010193 | K052377 | 000 |