Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K162553 |
Device Name |
AirSpiral Heated Breathing Tube |
Applicant |
FISHER & PAYKEL HEALTHCARE |
15 MAURICE PAYKEL PLACE, EAST TAMAKI |
AUCKLAND,
NZ
2013
|
|
Applicant Contact |
STEPHANIE ELVIN |
Correspondent |
FISHER & PAYKEL HEALTHCARE |
15 MAURICE PAYKEL PLACE, EAST TAMAKI |
AUCKLAND,
NZ
2013
|
|
Correspondent Contact |
Brett Whiston |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 09/13/2016 |
Decision Date | 12/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|