Device Classification Name |
Apparatus, Nitric Oxide Delivery
|
510(k) Number |
K093260 |
Device Name |
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM |
Applicant |
INTERNATIONAL BIOMEDICAL, LTD. |
8508 CROSS PARK DR. |
AUSTIN,
TX
78754
|
|
Applicant Contact |
AMY PIEPER |
Correspondent |
INTERNATIONAL BIOMEDICAL, LTD. |
8508 CROSS PARK DR. |
AUSTIN,
TX
78754
|
|
Correspondent Contact |
AMY PIEPER |
Regulation Number | 868.5165
|
Classification Product Code |
|
Date Received | 10/19/2009 |
Decision Date | 12/16/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|