Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K191010 |
Device Name |
Palladium High Flow Therapy System |
Applicant |
Vapotherm, Inc. |
100 Domain Drive |
Exeter,
NH
03833
|
|
Applicant Contact |
Richelle Helman |
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 | 04/16/2019 |
Decision Date | 10/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|