Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K161412 |
Device Name |
F&P Brevida™ Nasal Pillows Mask |
Applicant |
Fisher & Paykel Healthcare Ltd. |
15 Maurice Paykel Place, East Tamaki |
Auckland,
NZ
2013
|
|
Applicant Contact |
Amelia Ortiz |
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 | 05/20/2016 |
Decision Date | 01/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|