The following data is part of a premarket notification filed by Drgem Corporation with the FDA for Digital Diagnostic X-ray System.
| Device ID | K102408 |
| 510k Number | K102408 |
| Device Name: | DIGITAL DIAGNOSTIC X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | DRGEM CORPORATION 77325 JOYCE WAY Ehco, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack DRGEM CORPORATION 77325 JOYCE WAY Ehco, OR 97826 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-23 |
| Decision Date | 2010-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800011140168 | K102408 | 000 |
| 08800011140151 | K102408 | 000 |
| 08800011140014 | K102408 | 000 |
| 08800011140007 | K102408 | 000 |