The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Medical Systems, M3012a- Hemodynamic Extension To The Multi-measurement Server.
| Device ID | K033444 |
| 510k Number | K033444 |
| Device Name: | PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Tapan D Shah |
| Correspondent | Tapan D Shah PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-29 |
| Decision Date | 2003-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838021532 | K033444 | 000 |
| 00884838009783 | K033444 | 000 |
| 00884838009776 | K033444 | 000 |
| 00884838006942 | K033444 | 000 |
| 00690103219104 | K033444 | 000 |
| 00690103219111 | K033444 | 000 |