Cleared Traditional

RETINOMETER

K781507 · Coburn Optical Ind., Inc. · Ophthalmic
Nov 1978
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K781507 is an FDA 510(k) clearance for the RETINOMETER, a Instrument, Visual Field, Laser (Class II — Special Controls, product code HPJ), submitted by Coburn Optical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1978, 75 days after receiving the submission on September 1, 1978. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1360.

Submission Details

510(k) Number K781507 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1978
Decision Date November 15, 1978
Days to Decision 75 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPJ — Instrument, Visual Field, Laser
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1360