Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K180474 |
Device Name |
TNI softFlow 50 |
Applicant |
TNI Medical AG |
Hofmannstr. 8 |
Wuerzburg,
DE
97084
|
|
Applicant Contact |
Joseph P. McMenamin |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
Warren,
NJ
07059
|
|
Correspondent Contact |
DAVE YUNGVIRT |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 02/22/2018 |
Decision Date | 10/18/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|