Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K080439 |
Device Name |
SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE |
Applicant |
MALLINCKRODT DEVELOPPEMENT FRANCE |
6135 GUNBARELL AVE. |
BOULDER,
CO
80301
|
|
Applicant Contact |
TINA DREILING |
Correspondent |
MALLINCKRODT DEVELOPPEMENT FRANCE |
6135 GUNBARELL AVE. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
TINA DREILING |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 02/19/2008 |
Decision Date | 05/16/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|