The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Sentry Web Smartinterp.
Device ID | K153654 |
510k Number | K153654 |
Device Name: | Sentry WEB SmartInterp |
Classification | Computer, Diagnostic, Programmable |
Applicant | CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg, DE 97204 |
Contact | Elmar Niedermeyer |
Correspondent | Elmar Niedermeyer CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg, DE 97204 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-12-21 |
Decision Date | 2016-09-16 |
Summary: | summary |