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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K901881
Device Name VIBROMETRY SYSTEM
Applicant
Bruel & Kjaer Instruments, Inc.
555 W. Central Rd.
Hoffman Estates,  IL  60195
Applicant Contact FRED F FEY
Correspondent
Bruel & Kjaer Instruments, Inc.
555 W. Central Rd.
Hoffman Estates,  IL  60195
Correspondent Contact FRED F FEY
Classification Product Code
LNN
Date Received04/26/1990
Decision Date 05/31/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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