Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K003894 |
Device Name |
ORACLE ORAL MASK |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI,
NZ
|
|
Applicant Contact |
DARRYN ALEXANDER |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
15 MAURICE PAYKEL PLACE |
EAST TAMAKI,
NZ
|
|
Correspondent Contact |
DARRYN ALEXANDER |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 12/18/2000 |
Decision Date | 06/25/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|