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 |