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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K243244
Device Name Heated Breathing Tube
Applicant
Guangdong Eda Technology Co., Ltd.
# 6, Ma'An 2nd Rd., Chashan Town
Guangdong Province,  CN 523393
Applicant Contact Kant Huang
Correspondent
MCRA, LLC
803 7th St., NW, 3rd Floor
Washington, Dc,  DC  20001
Correspondent Contact Todd Courtney
Regulation Number868.5270
Classification Product Code
BZE  
Date Received10/11/2024
Decision Date 07/25/2025
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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