Clearance Summary
Electromed SmartVest Airway Clearance System received FDA 510(k) clearance under submission number K222496, sponsored by Electromed, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2022-11-18.
- Submission: K222496
- Applicant / Sponsor: Electromed, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5665
- Decision date: 2022-11-18
Classification & Regulation
This clearance is catalogued under FDA product code BYI and 21 CFR 868.5665, within the Anesthesiology review panel as a Class II device.