Device Classification Name |
Conserver, Oxygen
|
510(k) Number |
K051540 |
Device Name |
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR |
Applicant |
INOVO, INC. |
2975 S. HORSESHOE DRIVE |
SUITE 600 |
NAPLES,
FL
34104
|
|
Applicant Contact |
KEVIN CONFOY |
Correspondent |
INOVO, INC. |
2975 S. HORSESHOE DRIVE |
SUITE 600 |
NAPLES,
FL
34104
|
|
Correspondent Contact |
KEVIN CONFOY |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/10/2005 |
Decision Date | 09/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|