Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K041900 |
Device Name |
HC604 CPAP HUMIDIFIER |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI, AUCKLAND,
NZ
1701
|
|
Applicant Contact |
JAMES THOMPSON |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI, AUCKLAND,
NZ
1701
|
|
Correspondent Contact |
JAMES THOMPSON |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/14/2004 |
Decision Date | 08/31/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|