The following data is part of a premarket notification filed by Apelem-dms Group with the FDA for Platinum Drf Imaging System.
| Device ID | K203010 |
| 510k Number | K203010 |
| Device Name: | Platinum DRF Imaging System |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Apelem-DMS Group Parc Scientifique Georges Besse 175 Alle Von Neumann Nimes, FR 30005 |
| Contact | Samuel Sancerni |
| Correspondent | Scott Blood 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 | 2020-10-01 |
| Decision Date | 2021-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760172650430 | K203010 | 000 |
| 03760172650508 | K203010 | 000 |
| 03760172650485 | K203010 | 000 |
| 03760172650447 | K203010 | 000 |
| 03760172650409 | K203010 | 000 |