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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
BZQ  
Date Received06/05/2020
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
Predetermined Change
Control Plan Authorized		 No
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