STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR

Gauge, Pressure, Coronary, Cardiopulmonary Bypass

SHILEY, INC.

The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Stockert Shiley Dual Pressure Control Module Xr.

Pre-market Notification Details

Device IDK900797
510k NumberK900797
Device Name:STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
ClassificationGauge, Pressure, Coronary, Cardiopulmonary Bypass
Applicant SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
ContactAbati, Phd
CorrespondentAbati, Phd
SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine,  CA  92714
Product CodeDXS  
CFR Regulation Number870.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-20
Decision Date1990-05-10

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