The following data is part of a premarket notification filed by Sicat Gmbh & Co. Kg with the FDA for Sicat Function.
Device ID | K133320 |
510k Number | K133320 |
Device Name: | SICAT FUNCTION |
Classification | System, Image Processing, Radiological |
Applicant | SICAT GMBH & CO. KG BRUNNENALLEE 6 Bonn, DE D-53177 |
Contact | Manfred Breuer |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-10-28 |
Decision Date | 2014-02-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D776SUITEV20 | K133320 | 000 |
D776FUNCTIONV20 | K133320 | 000 |
D776SUITEV200 | K133320 | 000 |
D776FUNCTIONV200 | K133320 | 000 |
D77664556330 | K133320 | 000 |
D776FUNCTIONV20400 | K133320 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SICAT FUNCTION 79142787 4665280 Live/Registered |
SiCAT GmbH & Co. KG 2013-08-07 |