510(k) K201418
K201418 is an FDA 510(k) premarket notification submitted by Sunset Healthcare Solutions, Inc. for the device "Sunset Heated CPAP Tube". The FDA issued a decision of Substantially Equivalent on January 29, 2021. 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. Sunset Healthcare Solutions, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2021
- Date Received
- May 29, 2020
- 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