The following data is part of a premarket notification filed by Radlink, Inc. with the FDA for Radlink Gps.
| Device ID | K142718 |
| 510k Number | K142718 |
| Device Name: | Radlink GPS |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | RADLINK, INC. 815 N. Nash St. El Sugundo, CA 90245 |
| Contact | Brian Kordich |
| Correspondent | Daniel Kamm Kamm & Associates 8870 RAVELLO CT. Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-23 |
| Decision Date | 2014-12-17 |
| Summary: | summary |