Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K041963 |
Device Name |
AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI |
Applicant |
AMERICAN BANTEX CORP. |
994 NORTH MAIN STREET |
BOUNTIFUL,
UT
84010
|
|
Applicant Contact |
TRACY S BEST |
Correspondent |
AMERICAN BANTEX CORP. |
994 NORTH MAIN STREET |
BOUNTIFUL,
UT
84010
|
|
Correspondent Contact |
TRACY S BEST |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 07/21/2004 |
Decision Date | 10/20/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|