The following data is part of a premarket notification filed by Dgh Technology, Inc. with the FDA for Dgh-500 Pachymeter.
| Device ID | K920906 |
| 510k Number | K920906 |
| Device Name: | DGH-500 PACHYMETER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DGH TECHNOLOGY, INC. 446 LANCASTER AVE. Frazer, PA 19355 |
| Contact | Luther Detweiler |
| Correspondent | Luther Detweiler DGH TECHNOLOGY, INC. 446 LANCASTER AVE. Frazer, PA 19355 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-27 |
| Decision Date | 1992-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857377006315 | K920906 | 000 |
| 00857377006308 | K920906 | 000 |
| 00857377006216 | K920906 | 000 |
| 00857377006209 | K920906 | 000 |