Cleared Traditional

IRAS GLARE TESTER

K873987 · Randwal Instrument Co., Inc. · Ophthalmic
Nov 1987
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K873987 is an FDA 510(k) clearance for the IRAS GLARE TESTER, a Ophthalmoscope, Battery-powered (Class II — Special Controls, product code HLJ), submitted by Randwal Instrument Co., Inc. (Southbridge, US). The FDA issued a Cleared decision on November 24, 1987, 56 days after receiving the submission on September 29, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K873987 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1987
Decision Date November 24, 1987
Days to Decision 56 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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