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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 K791505
Device Name ROHNAR 7000 DIGITAL DIAGN ULTRASOUND
Applicant
Roche Scientific Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Roche Scientific Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/03/1979
Decision Date 09/17/1979
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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