The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Cl Sp02 Pod Model 865215, Intellivue Cl Nbp Pod Model 865216, Intellivue Patient Monitors Mp5, Mp2, X2 Model.
| Device ID | K101600 |
| 510k Number | K101600 |
| Device Name: | INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL |
| Classification | Oximeter |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Contact | Markus Stacha |
| Correspondent | Markus Stacha PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DRQ |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | DXQ |
| Subsequent Product Code | MHX |
| Subsequent Product Code | MSX |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-08 |
| Decision Date | 2010-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838033344 | K101600 | 000 |
| 20884838013616 | K101600 | 000 |
| 20884838013623 | K101600 | 000 |
| 30884838020888 | K101600 | 000 |
| 30884838030887 | K101600 | 000 |
| 30884838030900 | K101600 | 000 |
| 00884838020863 | K101600 | 000 |
| 00884838020870 | K101600 | 000 |
| 00884838030879 | K101600 | 000 |
| 00884838033337 | K101600 | 000 |
| 20884838013609 | K101600 | 000 |