IBC VENT VALVE, MODEL 1400

Valve, Pressure Relief, Cardiopulmonary Bypass

INTERNATIONAL BIOPHYSICS CORP.

The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Ibc Vent Valve, Model 1400.

Pre-market Notification Details

Device IDK992964
510k NumberK992964
Device Name:IBC VENT VALVE, MODEL 1400
ClassificationValve, Pressure Relief, Cardiopulmonary Bypass
Applicant INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin,  TX  78744
ContactH. David Shocklet, Jr
CorrespondentH. David Shocklet, Jr
INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin,  TX  78744
Product CodeMNJ  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-02
Decision Date1999-11-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.