HUMID-VENT 2

Condenser, Heat And Moisture (artificial Nose)

GIBECK, INC.

The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Humid-vent 2.

Pre-market Notification Details

Device IDK952844
510k NumberK952844
Device Name:HUMID-VENT 2
ClassificationCondenser, Heat And Moisture (artificial Nose)
Applicant GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis,  IN  46236
ContactBrian Grigsby
CorrespondentBrian Grigsby
GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis,  IN  46236
Product CodeBYD  
CFR Regulation Number868.5375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-21
Decision Date1995-07-20

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