The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin Connect Data Management System.
Device ID | K131816 |
510k Number | K131816 |
Device Name: | SORIN CONNECT DATA MANAGEMENT SYSTEM |
Classification | Display, Cathode-ray Tube, Medical |
Applicant | SORIN GROUP DEUTSCHLAND GMBH LINDBERGH STRASSE 25 Munchen, DE 80939 |
Contact | Renate Goebert |
Correspondent | Olaf Teichert TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
Product Code | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-06-20 |
Decision Date | 2013-07-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04033817901587 | K131816 | 000 |
04033817901570 | K131816 | 000 |
04033817900689 | K131816 | 000 |
04033817900672 | K131816 | 000 |