510(k) K902628

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

K902628 is an FDA 510(k) premarket notification submitted by Biometric Research Institute, Inc. for the device "INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT". The FDA issued a decision of Substantially Equivalent on February 25, 1991. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Biometric Research Institute, Inc. has at least 1 other 510(k) clearance on record.