Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K023559 |
Device Name |
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
P.O BOX 14-348 |
PANMURE, AUCKLAND,
NZ
1701
|
|
Applicant Contact |
KEVIN SHERLOCK |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
P.O BOX 14-348 |
PANMURE, AUCKLAND,
NZ
1701
|
|
Correspondent Contact |
KEVIN SHERLOCK |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 10/23/2002 |
Decision Date | 06/12/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|