The following data is part of a premarket notification filed by Dgh Technology, Inc. with the FDA for Dgh 55 Handheld Pachymeter (pachmate).
| Device ID | K033385 |
| 510k Number | K033385 |
| Device Name: | DGH 55 HANDHELD PACHYMETER (PACHMATE) |
| 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 ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-23 |
| Decision Date | 2003-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857377006353 | K033385 | 000 |
| 00857377006346 | K033385 | 000 |
| 00857377006339 | K033385 | 000 |
| 00857377006322 | K033385 | 000 |
| 00857377006247 | K033385 | 000 |
| 00857377006018 | K033385 | 000 |
| 00857377006001 | K033385 | 000 |