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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 K852502
Device Name AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849
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 Received06/12/1985
Decision Date 10/23/1986
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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