Cleared Traditional

ELECTRORETINOGRAPH

K760199 · Lkc Technologies, Inc. · Ophthalmic
Aug 1976
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K760199 is an FDA 510(k) clearance for the ELECTRORETINOGRAPH, a Electrode, Corneal (Class II — Special Controls, product code HLZ), submitted by Lkc Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1976, 28 days after receiving the submission on July 7, 1976. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1220.

Submission Details

510(k) Number K760199 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1976
Decision Date August 04, 1976
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HLZ — Electrode, Corneal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1220