Cleared Traditional

MEDICAL EXAMINATION LIGHTS

K851742 · Burton Medical Products Corp. · General Hospital
May 1985
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K851742 is an FDA 510(k) clearance for the MEDICAL EXAMINATION LIGHTS, a Device, Medical Examination, Ac Powered (Class I — General Controls, product code KZF), submitted by Burton Medical Products Corp. (Van Nuys, US). The FDA issued a Cleared decision on May 13, 1985, 14 days after receiving the submission on April 29, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number K851742 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1985
Decision Date May 13, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

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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