Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K220012 |
Device Name |
BresoDX1 |
Applicant |
Bresotec Inc |
55 York Street Unit 200 |
Toronto,
CA
M5J 1R7
|
|
Applicant Contact |
Esther Sur |
Correspondent |
Bresotec Inc |
55 York Street Unit 200 |
Toronto,
CA
M5J 1R7
|
|
Correspondent Contact |
Mehrnaz Tabibi |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 01/04/2022 |
Decision Date | 12/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04897399
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|