FDA 510(k) Application Details - K191728

Device Classification Name	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea   More FDA Info for this Device
510(K) Number	K191728
Device Name	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Applicant	Bryggs Medical, LLC 34910 Commerce Way Avon, OH 44011 US Other 510(k) Applications for this Company
Contact	Geoffrey Sleeper Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	OHP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2019
Decision Date	02/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
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