Device Classification Name |
Unit, Liquid-Oxygen, Portable
|
510(k) Number |
K072723 |
Device Name |
RESPIRONICS GOLOX |
Applicant |
RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY |
MONROEVILLE,
PA
15146
|
|
Applicant Contact |
ZITA A YURKO |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 868.5655
|
Classification Product Code |
|
Date Received | 09/26/2007 |
Decision Date | 03/20/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|