Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K092846 |
Device Name |
AIRVO SERIES HUMIDIFIERS |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI, AUCKLAND,
NZ
2013
|
|
Applicant Contact |
JAMES THOMPSON |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI, AUCKLAND,
NZ
2013
|
|
Correspondent Contact |
JAMES THOMPSON |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 09/15/2009 |
Decision Date | 01/27/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|