Device Classification Name |
Regulator, Pressure, Gas Cylinder
|
510(k) Number |
K061785 |
Device Name |
CYL-FIL OXYGEN SYSTEM |
Applicant |
RESPONSIVE RESPIRATORY INC. |
261 WOLFNER DRIVE |
FENTON,
MO
63026
|
|
Applicant Contact |
THOMAS BANNON |
Correspondent |
RESPONSIVE RESPIRATORY INC. |
261 WOLFNER DRIVE |
FENTON,
MO
63026
|
|
Correspondent Contact |
THOMAS BANNON |
Regulation Number | 868.2700
|
Classification Product Code |
|
Date Received | 06/23/2006 |
Decision Date | 09/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|