The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Patient Monitor.
Device ID | K151681 |
510k Number | K151681 |
Device Name: | IntelliVue Patient Monitor |
Classification | Detector And Alarm, Arrhythmia |
Applicant | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, DE 71034 |
Contact | Johannes Schmid |
Correspondent | Johannes Schmid PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, DE 71034 |
Product Code | DSI |
Subsequent Product Code | DRQ |
Subsequent Product Code | DSJ |
Subsequent Product Code | DSK |
Subsequent Product Code | DXG |
Subsequent Product Code | DXN |
Subsequent Product Code | MHX |
Subsequent Product Code | MLD |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-22 |
Decision Date | 2015-07-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838073579 | K151681 | 000 |
00884838072251 | K151681 | 000 |
00884838051492 | K151681 | 000 |
10884838073583 | K151681 | 000 |