Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K190713 |
Device Name |
F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) |
Applicant |
Fisher & Paykel Healthcare Ltd. |
15 Maurice Paykel Place, East Tamaki |
Auckland,
NZ
2013
|
|
Applicant Contact |
Masar Mohammad |
Correspondent |
Fisher & Paykel Healthcare Ltd. |
15 Maurice Paykel Place, East Tamaki |
Auckland,
NZ
2013
|
|
Correspondent Contact |
Masar Mohammad |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/19/2019 |
Decision Date | 10/11/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|