Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K200089 |
Device Name |
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model |
Applicant |
Fisher & Paykel Healthcare Ltd. |
15 Maurice Paykel Place, East Tamaki |
Auckland,
NZ
2013
|
|
Applicant Contact |
Reena Daken |
Correspondent |
Fisher & Paykel Healthcare Ltd. |
15 Maurice Paykel Place, East Tamaki |
Auckland,
NZ
2013
|
|
Correspondent Contact |
Reena Daken |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 01/15/2020 |
Decision Date | 06/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|