Cleared Traditional

SR-1V DATA PRINTER

K812063 · American Optical Corp. · Ophthalmic
Aug 1981
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K812063 is an FDA 510(k) clearance for the SR-1V DATA PRINTER, a Refractometer, Ophthalmic (Class I — General Controls, product code HKO), submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on August 18, 1981, 28 days after receiving the submission on July 21, 1981. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number K812063 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1981
Decision Date August 18, 1981
Days to Decision 28 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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