The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Mp60, Mp70 And Mp90 Intellivue Patient Monitors With Portal Technology And M3185 Opt C41 Wireless Bedside Adaptr.
Device ID | K030038 |
510k Number | K030038 |
Device Name: | PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
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 | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-01-06 |
Decision Date | 2003-03-12 |
Summary: | summary |