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510(k) K241268

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) by Exceleron Medical — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2024
Date Received
May 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type

Other clearances by Exceleron Medical

  • K131626 — EXCELERON BACTERIAL FILTERS (February 26, 2014)

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