The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Philips Intellivue Mp2/mp5/mpsc Patient Monitors, Philips Intellivue X1 And X2 Multi-msrmt-modules For Use With Intellivue Patient Monitors.
Device ID | K150975 |
510k Number | K150975 |
Device Name: | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 And X2 Multi-msrmt-modules For Use With IntelliVue Patient Monitors |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Hewlett-Packard Str. 2 Boeblingen, Baden Wuerttemberg, DE 71034 |
Contact | Michael Asmalsky |
Correspondent | Michael Asmalsky PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Hewlett-Packard Str. 2 Boeblingen, Baden Wuerttemberg, DE 71034 |
Product Code | MHX |
Subsequent Product Code | DQA |
Subsequent Product Code | DSB |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-13 |
Decision Date | 2015-06-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838055094 | K150975 | 000 |