TAP PAP NASAL PILLOW MASK


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K122350
Device Name TAP PAP NASAL PILLOW MASK
Applicant
AIRWAY MANAGEMENT, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
AIRWAY MANAGEMENT, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 08/03/2012
Decision Date 11/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No