The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Multi-measurement Module Mmx.
Device ID | K181831 |
510k Number | K181831 |
Device Name: | IntelliVue Multi-Measurement Module MMX |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 Boeblingen, DE 71034 |
Contact | Stefan Breuer |
Correspondent | Stefan Breuer Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 Boeblingen, DE 71034 |
Product Code | MHX |
Subsequent Product Code | DRQ |
Subsequent Product Code | DSI |
Subsequent Product Code | DSJ |
Subsequent Product Code | DSK |
Subsequent Product Code | DXG |
Subsequent Product Code | DXN |
Subsequent Product Code | MLD |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-09 |
Decision Date | 2018-11-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838086760 | K181831 | 000 |