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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K912562
Device Name ABCOM 2000
Applicant
Applied Biometrics, Inc.
6269 Bury Dr.
Eden Prairie,  MN  55346
Applicant Contact CLAIRE HOVLAND
Correspondent
Applied Biometrics, Inc.
6269 Bury Dr.
Eden Prairie,  MN  55346
Correspondent Contact CLAIRE HOVLAND
Regulation Number870.2100
Classification Product Code
DPW  
Date Received06/11/1991
Decision Date 01/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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