The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for Stingray Dr, Model 1.
| Device ID | K992794 |
| 510k Number | K992794 |
| Device Name: | STINGRAY DR, MODEL 1 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Contact | Ralph Flatau |
| Correspondent | Ralph Flatau INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-19 |
| Decision Date | 1999-11-09 |
| Summary: | summary |