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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 K911213
Device Name CUFFABLE
Applicant
Biomedical Dynamics, Inc.
12250 Nicollet Ave.
Burnsville,  MN  55337
Applicant Contact MATTHEW BELLIN
Correspondent
Biomedical Dynamics, Inc.
12250 Nicollet Ave.
Burnsville,  MN  55337
Correspondent Contact MATTHEW BELLIN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received03/19/1991
Decision Date 08/07/1991
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
Recalls CDRH Recalls
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