FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

M.E.D. LIGHT

K Number: K925710 · Decision Jun 4, 1993
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
36
Applicant Total
10
Review Days
204

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Basic Information

Device Name
M.E.D. LIGHT
K Number
K925710
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
880.6320
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Medical Illumination, Inc.
Date Received
November 12, 1992
Decision Date
June 4, 1993
Product Code
KZF
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KZF Device, Medical Examination, Ac Powered

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Other Clearances by Medical Illumination, Inc.

K Number Device Name
K931026 MI-5 DIAGNOSTIC LIGHT
K931646 MI-4 VARIABLE SPOT LIGHT
K930897 MI-15 EXAM SURGICAL LIGHT
K922278 ILLUMINATOR III
K922282 ILLUMINATOR VIII ULTRA/SPOT
K922281 ILLUMINATOR VII MINI/SPOT LIGHT
K922280 ILLUMINATOR VII MINI/LUM LIGHT
K922277 ILLUMINATOR II
K922279 ILLUMINATOR IV MINOR SURGERY LIGHT