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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
510(k) Number K180619
Device Name Bongo
Applicant
Innomed Healthscience, Inc.
1701 W. Hillsboro Blvd., Suite 303
Deerfield Beach,  FL  33442
Applicant Contact Javier Collazo
Correspondent
Innomed Healthscience, Inc. C/O Promedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number872.5570
Classification Product Code
OHP  
Date Received03/09/2018
Decision Date 08/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT02878590
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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