meddevicedb.com FDA Device Reference

ensoETM

DEN230021 Class II Direct
Decision Date
2023-09-13
Sponsor / Applicant
Advanced Cooling Therapy, Inc. D/B/A Attune Medical

Technical Specification

510(k) Submission ID DEN230021
Product Code QXV
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5720
Decision Date 2023-09-13
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ensoETM received FDA 510(k) clearance under submission number DEN230021, sponsored by Advanced Cooling Therapy, Inc. D/B/A Attune Medical. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-09-13.

Classification & Regulation

This clearance is catalogued under FDA product code QXV and 21 CFR 870.5720, within the Cardiovascular review panel as a Class II device.