Glaukon

FDA 510(k) K820751 · Sonometrics Systems, Inc.

Substantially Equivalent

510(k) numberK820751

Submission

Device name
Glaukon
Applicant
Sonometrics Systems, Inc.
Mchenry, IL, US
Received
March 19, 1982
Decision date
April 9, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HKX – Tonometer, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1930
Specialty
Ophthalmic

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Questions and answers

When was Glaukon cleared by the FDA?

Glaukon (K820751) received a 510(k) decision of Substantially Equivalent on April 9, 1982, 21 days after the submission was received.

What is the product code of K820751?

The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.