FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS

K Number: K912531 · Decision Sep 4, 1991
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
97
Applicant Total
1
Review Days
89

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Basic Information

Device Name
IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS
K Number
K912531
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.1500
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Innovative Medical Devices, Inc.
Date Received
June 7, 1991
Decision Date
September 4, 1991
Product Code
FET
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

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

Product Code Device Name
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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