Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K203155 |
Device Name |
BreatheSuite MDI V1 |
Applicant |
BreatheSuite Inc |
29 Rowan Street |
Unit 2 |
St. John's,
CA
A1B2X2
|
|
Applicant Contact |
Brett Vokey |
Correspondent |
BreatheSuite Inc |
29 Rowan Street |
Unit 2 |
St. John's,
CA
A1B2X2
|
|
Correspondent Contact |
Brett Vokey |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 10/22/2020 |
Decision Date | 09/17/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|