Clearance Summary
EnsoETM received FDA 510(k) clearance under submission number K180742, sponsored by Advanced Cooling Therapy, Inc. D/B/A Attune Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-05-17.
- Submission: K180742
- Applicant / Sponsor: Advanced Cooling Therapy, Inc. D/B/A Attune Medical
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5910
- Decision date: 2018-05-17
Classification & Regulation
This clearance is catalogued under FDA product code PLA and 21 CFR 870.5910, within the Cardiovascular review panel as a Class II device.