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 |