The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for 35mm Angiogram Viewer Analyzer.
| Device ID | K821491 |
| 510k Number | K821491 |
| Device Name: | 35MM ANGIOGRAM VIEWER ANALYZER |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | BIRTCHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-18 |
| Decision Date | 1982-07-08 |