SIMPLYGO PORTABLE OXYGEN CONCENTRATOR


Device Classification Name

generator, oxygen, portable

510(k) Number K111885
Device Name SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
Applicant
RESPIRONICS INC.
1740 golden mile highway
monroeville, 
PA 
15146

Applicant Contact joseph e olsavsky
Correspondent
RESPIRONICS INC.
1740 golden mile highway
monroeville, 
PA 
15146

Correspodent Contact joseph e olsavsky
Regulation Number 868.5440
Classification Product Code
CAW  
Date Received 07/01/2011
Decision Date 11/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No