Cleared Traditional

K914896 - FRIEDMANN ANALYSER 3
(FDA 510(k) Clearance)

Jan 1992
Decision
84d
Days
Class 1
Risk

K914896 is an FDA 510(k) clearance for the FRIEDMANN ANALYSER 3. This device is classified as a Screen, Tangent, Projection, Ac-powered (Class I - General Controls, product code HOK).

Submitted by Clement Clarke, Inc. (England, GB). The FDA issued a Cleared decision on January 23, 1992, 84 days after receiving the submission on October 31, 1991.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1810.

Submission Details

510(k) Number K914896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1991
Decision Date January 23, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HOK — Screen, Tangent, Projection, Ac-powered
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.1810