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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K883431
Device Name RAYMAX 2100 MODELS 2130 & 2136
Applicant
Raymax Medical Corp.
64 Trowers Rd.
Woodbridge
Ontario, L4l 7k5,  CA
Applicant Contact PRITCHARD
Correspondent
Raymax Medical Corp.
64 Trowers Rd.
Woodbridge
Ontario, L4l 7k5,  CA
Correspondent Contact PRITCHARD
Regulation Number892.1700
Classification Product Code
IZO  
Date Received08/15/1988
Decision Date 09/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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