Clearance Summary
External Counterpulsation System, Soulaire received FDA 510(k) clearance under submission number K202108, sponsored by Vamed Medical Instrument Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-08-28.
- Submission: K202108
- Applicant / Sponsor: Vamed Medical Instrument Co., Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5225
- Decision date: 2020-08-28
Classification & Regulation
This clearance is catalogued under FDA product code DRN and 21 CFR 870.5225, within the Cardiovascular review panel as a Class II device.