Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K132017 |
Device Name |
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI,
NZ
2013
|
|
Applicant Contact |
ELIZABETH GOLDSTEIN |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI,
NZ
2013
|
|
Correspondent Contact |
ELIZABETH GOLDSTEIN |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 07/01/2013 |
Decision Date | 03/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|