Device Classification Name |
ventilator, continuous, minimal ventilatory support, facility use
|
510(k) Number |
K170367 |
Device Name |
Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Ant |
Applicant |
Fisher and Paykel Healthcare Limited |
15 Maurice Paykel Place |
Auckland,
NZ
2013
|
|
Applicant Contact |
Danica Tung |
Correspondent |
Fisher and Paykel Healthcare Limited |
15 Maurice Paykel Place |
Auckland,
NZ
2013
|
|
Correspondent Contact |
Danica Tung |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 02/06/2017 |
Decision Date | 08/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|