The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Cl Respiration Pod.
Device ID | K132320 |
510k Number | K132320 |
Device Name: | INTELLIVUE CL RESPIRATION POD |
Classification | Monitor, Breathing Frequency |
Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Contact | Johannes Schmid |
Correspondent | Johannes Schmid PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-25 |
Decision Date | 2014-03-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838020689 | K132320 | 000 |