Device Classification Name |
valve, non-rebreathing
|
510(k) Number |
K111191 |
Device Name |
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE |
Applicant |
WET NOSE TECHNOLOGIES, LLC |
3750 2ND AVE |
LOS ANGELES,
CA
90018
|
|
Applicant Contact |
LIONEL NEWMAN |
Correspondent |
WET NOSE TECHNOLOGIES, LLC |
3750 2ND AVE |
LOS ANGELES,
CA
90018
|
|
Correspondent Contact |
LIONEL NEWMAN |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 04/28/2011 |
Decision Date | 07/28/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|