Cleared Traditional

K925710 - M.E.D. LIGHT (FDA 510(k) Clearance)

Jun 1993
Decision
204d
Days
Class 1
Risk

K925710 is an FDA 510(k) clearance for the M.E.D. LIGHT. This device is classified as a Device, Medical Examination, Ac Powered (Class I - General Controls, product code KZF).

Submitted by Medical Illumination, Inc. (Arleta, US). The FDA issued a Cleared decision on June 4, 1993, 204 days after receiving the submission on November 12, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number K925710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date June 04, 1993
Days to Decision 204 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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