The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Picosat Ii And M3002a Multimeasurement And M1020b Plug-in Modules Spo2 Pulse Oximetry Module.
| Device ID | K081937 |
| 510k Number | K081937 |
| Device Name: | PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE |
| Classification | Oximeter |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D-71034 |
| Contact | Jens-peter Seher |
| Correspondent | Jens-peter Seher 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-07 |
| Decision Date | 2008-08-29 |
| Summary: | summary |