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

MULTI-FORMAT FILM CAMERA

K Number: K843582 · Decision Oct 25, 1984
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
120
Applicant Total
6
Review Days
44

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Basic Information

Device Name
MULTI-FORMAT FILM CAMERA
K Number
K843582
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.2040
Medical Specialty
Radiology
Decision
Substantially Equivalent
Applicant
Bfi- Medical Waste Systems
Date Received
September 11, 1984
Decision Date
October 25, 1984
Product Code
LMC
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

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

Product Code Device Name
LMC Camera, Multi Format, Radiological

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