Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K040506 |
Device Name |
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI, AUCKLAND,
NZ
|
|
Applicant Contact |
JAMES THOMPSON |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI, AUCKLAND,
NZ
|
|
Correspondent Contact |
JAMES THOMPSON |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 02/27/2004 |
Decision Date | 05/05/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|