Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K220869 |
Device Name |
Vapotherm Aerosol Adapter AAA-2 |
Applicant |
Vapotherm Inc. |
100 Domain Drive |
Exeter,
NH
03833
|
|
Applicant Contact |
Michael J. Webb |
Correspondent |
Vapotherm Inc. |
100 Domain Drive |
Exeter,
NH
03833
|
|
Correspondent Contact |
Michael J. Webb |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 03/25/2022 |
Decision Date | 10/28/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|