Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K040726 |
Device Name |
VENTLAB NASAL CPAP CANNULA |
Applicant |
VENTLAB CORP. |
2934 HWY. 601 NORTH |
MOCKSVILLE,
NC
27028
|
|
Applicant Contact |
ROBERT M KELLY |
Correspondent |
VENTLAB CORP. |
2934 HWY. 601 NORTH |
MOCKSVILLE,
NC
27028
|
|
Correspondent Contact |
ROBERT M KELLY |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/22/2004 |
Decision Date | 06/03/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|