510(k) K241268
K241268 is an FDA 510(k) premarket notification submitted by Exceleron Medical for the device "Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)". The FDA issued a decision of Substantially Equivalent on August 2, 2024. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270. Exceleron Medical has at least 1 other 510(k) clearance on record.
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