The following data is part of a premarket notification filed by Dgh Technology, Inc. with the FDA for Dgh-4000 A-scan/pachymeter.
| Device ID | K913067 |
| 510k Number | K913067 |
| Device Name: | DGH-4000 A-SCAN/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 | 1991-07-11 |
| Decision Date | 1992-01-31 |