The following data is part of a premarket notification filed by Konica Minolta Healthcare Americas, Inc with the FDA for Otc Ddr.
| Device ID | K221853 |
| 510k Number | K221853 |
| Device Name: | OTC DDR |
| Classification | System, X-ray, Stationary |
| Applicant | Konica Minolta Healthcare Americas, Inc 2217 US Highway 70 East Garner, NC 27529 |
| Contact | Jan Maniscalco |
| Correspondent | Jan Maniscalco Konica Minolta Healthcare Americas, Inc 2217 US Highway 70 East Garner, NC 27529 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-27 |
| Decision Date | 2022-07-27 |