The following data is part of a premarket notification filed by Dgh Technology, Inc. with the FDA for Scanmate Flex.
| Device ID | K171301 |
| 510k Number | K171301 |
| Device Name: | Scanmate Flex |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DGH Technology, Inc. 110 Summit Drive, Suite B Exton, PA 19341 |
| Contact | David Henderson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-05-03 |
| Decision Date | 2017-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857377006162 | K171301 | 000 |
| 00857377006155 | K171301 | 000 |
| 00857377006148 | K171301 | 000 |
| 00857377006131 | K171301 | 000 |
| 00857377006124 | K171301 | 000 |
| 00857377006117 | K171301 | 000 |