The following data is part of a premarket notification filed by Sorin Group Deutschland Gmbh with the FDA for Sorin Connect.
Device ID | K170460 |
510k Number | K170460 |
Device Name: | Sorin Connect |
Classification | Display, Cathode-ray Tube, Medical |
Applicant | Sorin Group Deutschland GmbH Lindberghstrasse, 25 Munich, DE 80939 |
Contact | Luigi Vecchi |
Correspondent | Scott Light Sorin Group USA, Inc. 14401 W 65th Way Arvada, CO 80004 |
Product Code | DXJ |
CFR Regulation Number | 870.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-15 |
Decision Date | 2017-06-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04033817901594 | K170460 | 000 |