The following data is part of a premarket notification filed by Jamieson Film Co. with the FDA for Kodak Digital Science Cardiac Digital Acquisition Unit.
| Device ID | K970738 |
| 510k Number | K970738 |
| Device Name: | KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT |
| Classification | System, X-ray, Angiographic |
| Applicant | JAMIESON FILM CO. HEALTH SCIENCES DIVISION 901 ELMGROVE ROAD Rochester, NY 14653 -5741 |
| Contact | Dan Newman |
| Correspondent | Dan Newman JAMIESON FILM CO. HEALTH SCIENCES DIVISION 901 ELMGROVE ROAD Rochester, NY 14653 -5741 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-28 |
| Decision Date | 1997-05-07 |