COBE AEPS

Detector, Bubble, Cardiopulmonary Bypass

COBE LABORATORIES, INC.

The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Aeps.

Pre-market Notification Details

Device IDK842054
510k NumberK842054
Device Name:COBE AEPS
ClassificationDetector, Bubble, Cardiopulmonary Bypass
Applicant COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKRL  
CFR Regulation Number870.4205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-22
Decision Date1984-08-02

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