The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Silhouette Fc.
Device ID | K993090 |
510k Number | K993090 |
Device Name: | SILHOUETTE FC |
Classification | System, X-ray, Stationary |
Applicant | GE MEDICAL SYSTEMS, INC. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
Contact | Larry A Kroger |
Correspondent | Reiner Krumme TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 1999-09-16 |
Decision Date | 1999-10-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682120777 | K993090 | 000 |