The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Md-1835.
| Device ID | K964806 |
| 510k Number | K964806 |
| Device Name: | MD-1835 |
| Classification | Device, Spot-film |
| Applicant | FISCHER IMAGING CORP. 2301 WINDSOR CT. Addison, IL 60101 |
| Contact | William J Engel |
| Correspondent | William J Engel FISCHER IMAGING CORP. 2301 WINDSOR CT. Addison, IL 60101 |
| Product Code | IXL |
| CFR Regulation Number | 892.1670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-03-04 |