The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Mammotest Adapter Driver.
| Device ID | K973400 |
| 510k Number | K973400 |
| Device Name: | MAMMOTEST ADAPTER DRIVER |
| Classification | System, X-ray, Mammographic |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Sammuella D Enrich |
| Correspondent | Sammuella D Enrich FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-09 |
| Decision Date | 1997-11-10 |