Cleared Traditional

IRAS EDS INTERFEROMETRIC STIMULATOR

K873990 · Randwal Instrument Co., Inc. · Ophthalmic
Feb 1988
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K873990 is an FDA 510(k) clearance for the IRAS EDS INTERFEROMETRIC STIMULATOR, a Photostimulator, Ac-powered (Class II — Special Controls, product code HLX), submitted by Randwal Instrument Co., Inc. (Southbridge, US). The FDA issued a Cleared decision on February 5, 1988, 127 days after receiving the submission on October 1, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1630.

Submission Details

510(k) Number K873990 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 1987
Decision Date February 05, 1988
Days to Decision 127 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HLX — Photostimulator, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1630

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