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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K223863
Device Name BONHAWA Respiratory Humidifier
Applicant
Telesair, Inc.
204 Technology Dr., Suite F
Irvine,  CA  92618
Applicant Contact Yong (Bryan) Liu
Correspondent
ProMedic Consulting, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5450
Classification Product Code
BTT  
Date Received12/23/2022
Decision Date 10/13/2023
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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