CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4

Sensor, Blood-gas, In-line, Cardiopulmonary Bypass

INTERNATIONAL BIOPHYSICS CORP.

The following data is part of a premarket notification filed by International Biophysics Corp. with the FDA for Cm02 Cuvette, 1/2, Cm02 Cuvette, 3/8 And Cm02 Cuvette, 1/4.

Pre-market Notification Details

Device IDK963698
510k NumberK963698
Device Name:CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
ClassificationSensor, Blood-gas, In-line, Cardiopulmonary Bypass
Applicant INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin,  TX  78744
ContactH. David Shockley, Jr.
CorrespondentH. David Shockley, Jr.
INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR. SUITE 160 Austin,  TX  78744
Product CodeDTY  
CFR Regulation Number870.4410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-16
Decision Date1997-03-20
Summary:summary

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