The following data is part of a premarket notification filed by Del Medical, Inc. with the FDA for Otc12d Auto Radiographic System.
| Device ID | K152767 |
| 510k Number | K152767 |
| Device Name: | OTC12D AUTO RADIOGRAPHIC SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | DEL MEDICAL, INC. 241 COVINGTON DR. Bloomingdale, IL 60108 |
| Contact | John Hartzell |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-24 |
| Decision Date | 2015-12-14 |
| Summary: | summary |