The following data is part of a premarket notification filed by Apelem-dms Group with the FDA for Platinum Drf Imaging System.
| Device ID | K131766 |
| 510k Number | K131766 |
| Device Name: | PLATINUM DRF IMAGING SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | APELEM-DMS GROUP 200 Homer Ave Ashland, MA 01721 |
| Contact | Sharyn Orton |
| Correspondent | Sharyn Orton APELEM-DMS GROUP 200 Homer Ave Ashland, MA 01721 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-17 |
| Decision Date | 2013-12-12 |
| Summary: | summary |