ARABELLA NCPAP MASKS


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K030563
Device Name ARABELLA NCPAP MASKS
Applicant
HAMILTON MEDICAL AG
po box 30008
reno, 
NV 
89502

Applicant Contact j. david thompson
Correspondent
HAMILTON MEDICAL AG
po box 30008
reno, 
NV 
89502

Correspodent Contact j. david thompson
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 02/21/2003
Decision Date 09/09/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No