The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Picosat Ii Sp02 Pulse Oximetry Module And M3001a Multi-measurement Server.
| Device ID | K033715 |
| 510k Number | K033715 |
| Device Name: | PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER |
| Classification | Oximeter |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | David Osborn |
| Correspondent | David Osborn PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-26 |
| Decision Date | 2004-02-13 |
| Summary: | summary |