Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K161686 |
Device Name |
F&P InfoSmart |
Applicant |
FISHER & PAYKEL HEALTHCARE LTD. |
15 MAURICE PAYKEL PLACE |
East Tamaki,
NZ
2013
|
|
Applicant Contact |
Jayanti Karandikar |
Correspondent |
FISHER & PAYKEL HEALTHCARE LTD. |
15 MAURICE PAYKEL PLACE |
East Tamaki,
NZ
2013
|
|
Correspondent Contact |
Jayanti Karandikar |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/17/2016 |
Decision Date | 01/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|