The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Masimo Set Spo2 Module For Philips And M3001a Multi-measurement Server Option A03.
| Device ID | K062268 |
| 510k Number | K062268 |
| Device Name: | MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 |
| Classification | Oximeter |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 3000 MINUTEMAN ROAD Andover, MA 01810 -1099 |
| Contact | David Osborn |
| Correspondent | David Osborn PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 3000 MINUTEMAN ROAD 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 | 2006-08-07 |
| Decision Date | 2006-10-18 |
| Summary: | summary |