SOYALA GEL VENTED


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K081014
Device Name SOYALA GEL VENTED
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 04/09/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No