TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST

Gauge, Pressure, Coronary, Cardiopulmonary Bypass

LIFESTREAM INT'L, INC.

The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Tmp Pressure Isolatorr, Tmp Pressure Monitor Syst.

Pre-market Notification Details

Device IDK912045
510k NumberK912045
Device Name:TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
ClassificationGauge, Pressure, Coronary, Cardiopulmonary Bypass
Applicant LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands,  TX  77381
ContactKrista Oakes
CorrespondentKrista Oakes
LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands,  TX  77381
Product CodeDXS  
CFR Regulation Number870.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-08
Decision Date1991-10-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B0663014000007 K912045 000

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