The following data is part of a premarket notification filed by Dgh Technology, Inc. with the FDA for Model Dgh 6000 Scanmate A.
| Device ID | K093371 |
| 510k Number | K093371 |
| Device Name: | MODEL DGH 6000 SCANMATE A |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DGH TECHNOLOGY, INC. 110 SUMMIT DR., SUITE B Exton, PA 19341 |
| Contact | M. Luther Detweiler |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-29 |
| Decision Date | 2010-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857377006230 | K093371 | 000 |
| 00857377006094 | K093371 | 000 |