The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Philips Mp5 And Mp5t Intellivue Patient Monitors And Trx4841a Intellivue Telemetry System Transceiver.
Device ID | K081793 |
510k Number | K081793 |
Device Name: | PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D-71034 |
Contact | Markus Stacha |
Correspondent | Markus Stacha PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D-71034 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-25 |
Decision Date | 2008-10-14 |
Summary: | summary |