EnsoETM— 510(k) K180742
Substantially EquivalentAdvanced Cooling Therapy, Inc. D/B/A Attune Medical
FDA 510(k) clearance K180742 for EnsoETM, Substantially Equivalent on 2018-05-17. Applicant: Advanced Cooling Therapy, Inc. D/B/A Attune Medical.
Clearance details
- Applicant
- Advanced Cooling Therapy, Inc. D/B/A Attune Medical
- Product code
- Code PLA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.