Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K080209 |
Device Name |
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK |
Applicant |
FISHER & PAYKEL HEALTHCARE, LTD. |
P.O. BOX 14-348 |
AUCKLAND,
NZ
|
|
Applicant Contact |
TINA MASON |
Correspondent |
FISHER & PAYKEL HEALTHCARE, LTD. |
P.O. BOX 14-348 |
AUCKLAND,
NZ
|
|
Correspondent Contact |
TINA MASON |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 01/28/2008 |
Decision Date | 09/12/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|