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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 K241268
Device Name Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
Applicant
Exceleron Medical
5000 Township Pkwy.
St. Paul,  MN  55110
Applicant Contact Keith Roberts
Correspondent
ProMedic Consulting, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5270
Classification Product Code
BZE  
Subsequent Product Code
BZD  
Date Received05/06/2024
Decision Date 08/02/2024
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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