HOMELOX


Device Classification Name

generator, oxygen, portable

510(k) Number K081206
Device Name HOMELOX
Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Applicant Contact zita a yurko
Correspondent
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Correspodent Contact zita a yurko
Regulation Number 868.5440
Classification Product Code
CAW  
Date Received 04/29/2008
Decision Date 07/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No