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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bulb, Inflation, For Endoscope
510(k) Number K904376
Device Name ANEROID BLOOD PRESSURE GAUGE
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 Number876.1500
Classification Product Code
FCY  
Date Received09/25/1990
Decision Date 12/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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