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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K902628
Device Name INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT
Applicant
Biometric Research Institute, Inc.
1401 Wilson Blvd.
Suite 400
Arlington,  VA  22209
Applicant Contact A RAHMOELLER
Correspondent
Biometric Research Institute, Inc.
1401 Wilson Blvd.
Suite 400
Arlington,  VA  22209
Correspondent Contact A RAHMOELLER
Regulation Number870.1435
Classification Product Code
DXG  
Date Received06/13/1990
Decision Date 02/25/1991
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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