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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827409
Device Name REAL TIME ULTRASOUND SCANNER 1849
Applicant
Bruel & Kjaer Instruments, Inc.
185 Forest St.
Marlborough,  MA 
Correspondent
Bruel & Kjaer Instruments, Inc.
185 Forest St.
Marlborough,  MA 
Date Received04/30/1982
Decision Date 07/09/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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