The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Picosat Ii Spo2 Pulse Oximetry Module.
| Device ID | K030973 |
| 510k Number | K030973 |
| Device Name: | PICOSAT II SPO2 PULSE OXIMETRY MODULE |
| Classification | Oximeter |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | David Osborn |
| Correspondent | David Osborn PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. 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 | 2003-03-28 |
| Decision Date | 2003-07-23 |
| Summary: | summary |