MACS CPAP SYSTEM


Device Classification Name

ventilator, emergency, powered (resuscitator)

510(k) Number K080692
Device Name MACS CPAP SYSTEM
Applicant
AIRON CORPORATION
129 w. hibiscus blvd., suite s
melbourne, 
FL 
32901

Applicant Contact eric gjerde
Correspondent
AIRON CORPORATION
129 w. hibiscus blvd., suite s
melbourne, 
FL 
32901

Correspodent Contact eric gjerde
Regulation Number 868.5925
Classification Product Code
BTL  
Subsequent Product Code
BYE  
Date Received 03/11/2008
Decision Date 06/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No