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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 K201418
Device Name Sunset Heated CPAP Tube
Applicant
Sunset Healthcare Solutions, Inc.
180 N. Michigan Ave., Suite 2000
Chicago,  IL  60601
Applicant Contact N. (Nazree) Williams
Correspondent
Speed TO Market, Inc.
2235 E. Flamingo Rd., Suite 201g
Las Vegas,  NV  89119
Correspondent Contact Thomas Kroenke
Regulation Number868.5270
Classification Product Code
BZE  
Date Received05/29/2020
Decision Date 01/29/2021
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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