SOYALA SILKGEL FULL FACE MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K112167
Device Name SOYALA SILKGEL FULL FACE MASK
Applicant
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
kronsaalsweg 40
hamburg, 

DE

22525

Applicant Contact ralf egenolf
Correspondent
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
kronsaalsweg 40
hamburg, 

DE

22525

Correspodent Contact ralf egenolf
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 07/28/2011
Decision Date 11/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No