Cleared Traditional

PORTABLE ACUIOMETER

K842567 · Randwal Instrument Co., Inc. · Ophthalmic
Aug 1984
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K842567 is an FDA 510(k) clearance for the PORTABLE ACUIOMETER, a Ophthalmoscope, Battery-powered (Class II — Special Controls, product code HLJ), submitted by Randwal Instrument Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 15, 1984, 44 days after receiving the submission on July 2, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K842567 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1984
Decision Date August 15, 1984
Days to Decision 44 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HLJ — Ophthalmoscope, Battery-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

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