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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infusor, Pressure, For I.V. Bags
510(k) Number K913751
Device Name PRESSURE INFUSER
Applicant
Biomedical Dynamics, Inc.
12250 Nicollet Ave.
Burnsville,  MN  55337
Applicant Contact MATTHEW E BELLIN
Correspondent
Biomedical Dynamics, Inc.
12250 Nicollet Ave.
Burnsville,  MN  55337
Correspondent Contact MATTHEW E BELLIN
Regulation Number880.5420
Classification Product Code
KZD  
Date Received08/21/1991
Decision Date 01/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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