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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Blood Pressure Cuff
510(k) Number K881799
Device Name BLOOD PRESSURE CUFF
Applicant
Biomedical Dynamics, Inc.
3800 Multifoods Tower
33 S. Sixth St.
Minneapolis,  MN  55402
Applicant Contact JAMES W MOEN
Correspondent
Biomedical Dynamics, Inc.
3800 Multifoods Tower
33 S. Sixth St.
Minneapolis,  MN  55402
Correspondent Contact JAMES W MOEN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received04/27/1988
Decision Date 10/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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