BUBBLE TRAP-FILTER CAT. NO B180F37

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

AMERICAN OMNI MEDICAL, INC.

The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Bubble Trap-filter Cat. No B180f37.

Pre-market Notification Details

Device IDK873316
510k NumberK873316
Device Name:BUBBLE TRAP-FILTER CAT. NO B180F37
ClassificationFilter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa,  CA  92626
ContactGeorge G Siposs
CorrespondentGeorge G Siposs
AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa,  CA  92626
Product CodeDTM  
CFR Regulation Number870.4260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-19
Decision Date1988-07-14

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