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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 K191095
Device Name Maxxi Snore 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  
Date Received04/25/2019
Decision Date 01/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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