The following data is part of a premarket notification filed by Bayer Corp., Agfa Div. with the FDA for Adc Compact (agfa Diagnostic Center).
| Device ID | K974597 |
| 510k Number | K974597 |
| Device Name: | ADC COMPACT (AGFA DIAGNOSTIC CENTER) |
| Classification | System, X-ray, Stationary |
| Applicant | BAYER CORP., AGFA DIV. 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Contact | Michael Sullivan |
| Correspondent | Michael Sullivan BAYER CORP., AGFA DIV. 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-09 |
| Decision Date | 1998-03-09 |
| Summary: | summary |