The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Fvp-1000 Family And Fvp-1000d Family.
| Device ID | K905694 |
| 510k Number | K905694 |
| Device Name: | FVP-1000 FAMILY AND FVP-1000D FAMILY |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Richard S Lucas |
| Correspondent | Richard S Lucas FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-19 |
| Decision Date | 1991-11-27 |