HAMILTON-TC1


Device Classification Name

ventilator, continuous, facility use

510(k) Number K112006
Device Name HAMILTON-TC1
Applicant
HAMILTON MEDICAL AG
via crusch 8
bonaduz, 

CH

7402

Applicant Contact ralph aguila
Correspondent
HAMILTON MEDICAL AG
via crusch 8
bonaduz, 

CH

7402

Correspodent Contact ralph aguila
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 07/13/2011
Decision Date 02/09/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No