Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K110019 |
Device Name |
RESPIRATORY HUMIDIFER |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
P.O. BOX 14348, PANMURE |
AUCKLAND,
NZ
1741
|
|
Applicant Contact |
ADELE BINDON |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
P.O. BOX 14348, PANMURE |
AUCKLAND,
NZ
1741
|
|
Correspondent Contact |
ADELE BINDON |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 01/03/2011 |
Decision Date | 03/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|