510(k) K902628

INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT by Biometric Research Institute, Inc. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1991
Date Received
June 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type