Cleared Traditional

RELIANCE 1000, RELIANCE 1500, RELIANCE 2000

K853149 · F. & F. Koenigkramer · Ophthalmic
Sep 1985
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K853149 is an FDA 510(k) clearance for the RELIANCE 1000, RELIANCE 1500, RELIANCE 2000, 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 K853149 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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