FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

ALPHA

K Number: K930273 · Decision Jul 13, 1993
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
28
Applicant Total
3
Review Days
175

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Basic Information

Device Name
ALPHA
K Number
K930273
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.1980
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Raymax Medical Corp.
Date Received
January 19, 1993
Decision Date
July 13, 1993
Product Code
IZZ
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
IZZ Table, Radiographic, Non-Tilting, Powered

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Other Clearances by Raymax Medical Corp.

K Number Device Name
K914414 VIDEO FLUOROSCOPE
K883431 RAYMAX 2100 MODELS 2130 & 2136