Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K091538 |
Device Name |
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 |
Applicant |
WET NOSE TECHNOLOGIES, LLC |
3750 2ND AVE |
LOS ANGELES,
CA
90018
|
|
Applicant Contact |
JIM BARLEY |
Correspondent |
WET NOSE TECHNOLOGIES, LLC |
3750 2ND AVE |
LOS ANGELES,
CA
90018
|
|
Correspondent Contact |
JIM BARLEY |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 05/26/2009 |
Decision Date | 03/25/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|