NEWPORT AURA VENTILATOR


Device Classification Name

ventilator, continuous, facility use

510(k) Number K121891
Device Name NEWPORT AURA VENTILATOR
Applicant
NEWPORT MEDICAL INSTRUMENTS, INC.
1620 sunflower ave.
costa mesa, 
CA 
92626

Applicant Contact tom colonna
Correspondent
NEWPORT MEDICAL INSTRUMENTS, INC.
1620 sunflower ave.
costa mesa, 
CA 
92626

Correspodent Contact tom colonna
Regulation Number 868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received 06/29/2012
Decision Date 11/09/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No