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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 K862127
Device Name DYMAX PERSONAL SCANNER
Applicant
Dymax Corp
604 Epsilon Dr.
Pittsburgh,  PA  15238
Applicant Contact IRENE R SKOLNICK
Correspondent
Dymax Corp
604 Epsilon Dr.
Pittsburgh,  PA  15238
Correspondent Contact IRENE R SKOLNICK
Regulation Number892.1560
Classification Product Code
IYO  
Date Received06/04/1986
Decision Date 12/11/1986
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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