Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K201495 |
Device Name |
Maxxi Flow Sensor |
Applicant |
Neurovirtual USA, INC. |
3303 W Commercial Blvd #100 |
Fort Lauderdale,
FL
33309
|
|
Applicant Contact |
Eduardo Faria |
Correspondent |
Neurovirtual USA, INC. |
3303 W Commercial Blvd #100 |
Fort Lauderdale,
FL
33309
|
|
Correspondent Contact |
Eduardo Faria |
Regulation Number | 868.2375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/05/2020 |
Decision Date | 12/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|