STOCKERT 1/4 BUBBLE SENSOR

Detector, Bubble, Cardiopulmonary Bypass

SORIN BIOMEDICA, FIAT, USA, INC.

The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Stockert 1/4 Bubble Sensor.

Pre-market Notification Details

Device IDK925541
510k NumberK925541
Device Name:STOCKERT 1/4 BUBBLE SENSOR
ClassificationDetector, Bubble, Cardiopulmonary Bypass
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
ContactDavid Taylor
CorrespondentDavid Taylor
SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
Product CodeKRL  
CFR Regulation Number870.4205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-03
Decision Date1993-02-02

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