The following data is part of a premarket notification filed by Apelem-dms Group with the FDA for Platinum Drf Imaging System.
| Device ID | K160301 |
| 510k Number | K160301 |
| Device Name: | Platinum DRF Imaging System |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Apelem-DMS Group Parc Scientifique Georges Passe 175 Allee Von Neumann Nimes 30005, FR |
| Contact | Krishna Mahadea |
| Correspondent | Sharyn Orton MEDIcept, Inc 200 Homer Ave Ashland, MA 01721 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-04 |
| Decision Date | 2016-03-04 |
| Summary: | summary |