Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K093617 |
Device Name |
VENTLAB 6000 SERIES HUMIDIFIER |
Applicant |
VENTLAB CORP. |
155 BOYCE DRIVE |
MOCKSVILLE,
NC
27028
|
|
Applicant Contact |
JAMES A COCHIE |
Correspondent |
VENTLAB CORP. |
155 BOYCE DRIVE |
MOCKSVILLE,
NC
27028
|
|
Correspondent Contact |
JAMES A COCHIE |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 11/23/2009 |
Decision Date | 01/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|