Cleared Traditional

RELIANCE 6100

K853150 · F. & F. Koenigkramer · Ophthalmic
Sep 1985
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K853150 is an FDA 510(k) clearance for the RELIANCE 6100, a Chair, Ophthalmic, Ac-powered (Class I — General Controls, product code HME), submitted by F. & F. Koenigkramer (Cincinnati, US). The FDA issued a Cleared decision on September 5, 1985, 38 days after receiving the submission on July 29, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1140.

Submission Details

510(k) Number K853150 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1985
Decision Date September 05, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HME — Chair, Ophthalmic, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1140

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