SOYALA FULL FACE MASK

Ventilator, Non-continuous (respirator)

WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG

The following data is part of a premarket notification filed by Weinmann Gerate Fur Medizin Gmbh + Co. Kg with the FDA for Soyala Full Face Mask.

Pre-market Notification Details

Device IDK061653
510k NumberK061653
Device Name:SOYALA FULL FACE MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG KRONSAALSWEG 40 Hamburg,  DE 22525
ContactEckhardt Abers
CorrespondentEckhardt Abers
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG KRONSAALSWEG 40 Hamburg,  DE 22525
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-13
Decision Date2006-11-09
Summary:summary

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