PNEUTON VENTILATOR


Device Classification Name

ventilator, continuous, facility use

510(k) Number K024344
Device Name PNEUTON VENTILATOR
Original Applicant
AIRON CORPORATION
102 east new haven ave. #146
melbourne, 
FL 
32901

Original Contact g. eric gjerde
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 12/27/2002
Decision Date 06/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No