The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Cl Spo2 Pod And Cl Nbp Pod, Philips Intellivue Patient Monitors Mp5, Mp5t, Mp5sc.
Device ID | K131913 |
510k Number | K131913 |
Device Name: | INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, Bw, DE D-71034 |
Contact | Markus Stacha |
Correspondent | Markus Stacha PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR. 2 Boeblingen, Bw, DE D-71034 |
Product Code | DRG |
Subsequent Product Code | DQA |
Subsequent Product Code | DRQ |
Subsequent Product Code | DRT |
Subsequent Product Code | DSA |
Subsequent Product Code | DSI |
Subsequent Product Code | DSJ |
Subsequent Product Code | DSK |
Subsequent Product Code | DXG |
Subsequent Product Code | DXJ |
Subsequent Product Code | DXN |
Subsequent Product Code | DXQ |
Subsequent Product Code | MSX |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-26 |
Decision Date | 2013-11-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838020672 | K131913 | 000 |
00884838020665 | K131913 | 000 |