Device Classification Name |
ventilatory effort recorder
|
510(k) Number |
K171304 |
Device Name |
Maxxi Rip Sensor |
Applicant |
Neurovirtual USA, INC. |
2315 NW 107th Ave Suite# 1M27 |
Doral,
FL
33172
|
|
Applicant Contact |
Eduardo Faria |
Correspondent |
Neurovirtual USA, INC. |
2315 NW 107th Ave Suite# 1M27 |
Doral,
FL
33172
|
|
Correspondent Contact |
Eduardo Faria |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 05/03/2017 |
Decision Date | 06/24/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|