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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 K914945
Device Name DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED
Applicant
Bruel & Kjaer Industri A/S
18, Naerum Hovedgade
Dk-2850 Naerum
Denmark,  DK
Applicant Contact AAGE RUBY
Correspondent
Bruel & Kjaer Industri A/S
18, Naerum Hovedgade
Dk-2850 Naerum
Denmark,  DK
Correspondent Contact AAGE RUBY
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/04/1991
Decision Date 06/26/1992
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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