MODIFICATION TO GALILEO GOLD


Device Classification Name

ventilator, continuous, facility use

510(k) Number K080181
Device Name MODIFICATION TO GALILEO GOLD
Applicant
HAMILTON MEDICAL AG
via crusch 8
bonaduz, 

CH

ch-7402

Applicant Contact joerg schneider
Correspondent
HAMILTON MEDICAL AG
via crusch 8
bonaduz, 

CH

ch-7402

Correspodent Contact joerg schneider
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 01/24/2008
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No