Cleared Traditional

RITTER MODEL 158 AND 159 EXAM LIGHTS

K932719 · Midmark Corp. · General Hospital
Dec 1993
Decision
181d
Days
Class 1
Risk

About This 510(k) Submission

K932719 is an FDA 510(k) clearance for the RITTER MODEL 158 AND 159 EXAM LIGHTS, a Device, Medical Examination, Ac Powered (Class I — General Controls, product code KZF), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on December 2, 1993, 181 days after receiving the submission on June 4, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number K932719 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 1993
Decision Date December 02, 1993
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KZF — Device, Medical Examination, Ac Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6320

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