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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K844299
Device Name CORNEOMAP 4500
Applicant
Radionics Medical, Inc.
1240 Ellesmere Rd.
Scarborough, Ontario, Can,  CA
Applicant Contact WILLIAM L YOUNDER
Correspondent
Radionics Medical, Inc.
1240 Ellesmere Rd.
Scarborough, Ontario, Can,  CA
Correspondent Contact WILLIAM L YOUNDER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/07/1984
Decision Date 04/18/1985
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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