Clearance Summary
EnsoETM received FDA 510(k) clearance under submission number K180244, sponsored by Advanced Cooling Therapy, Inc. D/B/A Attune Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-02-28.
- Submission: K180244
- Applicant / Sponsor: Advanced Cooling Therapy, Inc. D/B/A Attune Medical
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5910
- Decision date: 2018-02-28
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.