Cleared Traditional

K812015 - GLAUKON (FDA 510(k) Clearance)

Feb 1982
Decision
206d
Days
Risk

K812015 is an FDA 510(k) clearance for the GLAUKON..

Submitted by Sonometrics Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1982, 206 days after receiving the submission on July 17, 1981.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K812015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1981
Decision Date February 08, 1982
Days to Decision 206 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code
Device Class