HUMID-VENT(R) 2 PORT

Condenser, Heat And Moisture (artificial Nose)

GIBECK RESPIRATION

The following data is part of a premarket notification filed by Gibeck Respiration with the FDA for Humid-vent(r) 2 Port.

Pre-market Notification Details

Device IDK873768
510k NumberK873768
Device Name:HUMID-VENT(R) 2 PORT
ClassificationCondenser, Heat And Moisture (artificial Nose)
Applicant GIBECK RESPIRATION 165 E. COMMERCE DR. Shaumburg,  IL  60173
ContactDarryl Lustig
CorrespondentDarryl Lustig
GIBECK RESPIRATION 165 E. COMMERCE DR. Shaumburg,  IL  60173
Product CodeBYD  
CFR Regulation Number868.5375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-16
Decision Date1987-11-24

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