DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES


Device Classification Name

generator, oxygen, portable

510(k) Number K081468
Device Name DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES
Applicant
SUNRISE MEDICAL
100 devilbiss dr.
somerset, 
PA 
15501

Applicant Contact joseph e olsavsky
Correspondent
SUNRISE MEDICAL
100 devilbiss dr.
somerset, 
PA 
15501

Correspodent Contact joseph e olsavsky
Regulation Number 868.5440
Classification Product Code
CAW  
Date Received 05/27/2008
Decision Date 08/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No