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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K890268
Device Name PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION
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 Number880.5025
Classification Product Code
KPE  
Date Received01/18/1989
Decision Date 05/05/1989
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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