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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K251133
Device Name AVEA disposable expiratory filter/water trap (11790)
Applicant
Telesair, Inc.
199 Technology Dr. Suite 110
Irvine,  CA  92618
Applicant Contact Don Lin
Correspondent
ProMedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/11/2025
Decision Date 05/08/2025
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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