Cleared Traditional

SR-IV PROGRAMMED SUBJECTIVE REFRACTOR

K802183 · American Optical Corp. · Ophthalmic
Apr 1981
Decision
226d
Days
Class 1
Risk

About This 510(k) Submission

K802183 is an FDA 510(k) clearance for the SR-IV PROGRAMMED SUBJECTIVE REFRACTOR, a Refractometer, Ophthalmic (Class I — General Controls, product code HKO), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981, 226 days after receiving the submission on September 9, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number K802183 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1980
Decision Date April 23, 1981
Days to Decision 226 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HKO — Refractometer, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1760

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