DGH-500 Pachymeter
FDA 510(k) K920906 · Dgh Technology, Inc.
510(k) numberK920906
Submission
- Device name
- DGH-500 Pachymeter
- Applicant
- Dgh Technology, Inc.
Frazer, PA, US - Received
- February 27, 1992
- Decision date
- November 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was DGH-500 Pachymeter cleared by the FDA?
DGH-500 Pachymeter (K920906) received a 510(k) decision of Substantially Equivalent on November 2, 1992, 249 days after the submission was received.
What is the product code of K920906?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.