MODIFICATION TO AVEA VENTILATOR


Device Classification Name

ventilator, continuous, facility use

510(k) Number K073069
Device Name MODIFICATION TO AVEA VENTILATOR
Applicant
VIASYS RESPIRATORY CARE INC
1100 bird center dr.
palm springs, 
CA 
92262

Applicant Contact tom gutierrez
Correspondent
VIASYS RESPIRATORY CARE INC
1100 bird center dr.
palm springs, 
CA 
92262

Correspodent Contact tom gutierrez
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 10/30/2007
Decision Date 01/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls