Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K033087 |
Device Name |
ORACLE ORAL MASK, MODEL HC451A |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI,
NZ
|
|
Applicant Contact |
JAMES THOMPSON |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI,
NZ
|
|
Correspondent Contact |
JAMES THOMPSON |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 09/29/2003 |
Decision Date | 01/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|