HELONTIX VENT


Device Classification Name

ventilator, continuous, facility use

510(k) Number K072926
Device Name HELONTIX VENT
Applicant
LINDE GAS THERAPEUTICS
aga ab
se-181 81lidingo, 

SE

Applicant Contact ann-cathrin jareman
Correspondent
LINDE GAS THERAPEUTICS
aga ab
se-181 81lidingo, 

SE

Correspodent Contact ann-cathrin jareman
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 10/15/2007
Decision Date 10/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No