The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Piconibp Oem Module.
Device ID | K051366 |
510k Number | K051366 |
Device Name: | PICONIBP OEM MODULE |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Contact | Markus Stacha |
Correspondent | Markus Stacha PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-25 |
Decision Date | 2005-09-14 |
Summary: | summary |