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FDA 510(k)

EnsoETM

K-Number: K180742 · 2018-05-17

ApplicantAdvanced Cooling Therapy, Inc. D/B/A Attune Medical
Decision Date2018-05-17
Product CodePLA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnsoETM is a medical device manufactured by Advanced Cooling Therapy, Inc. D/B/A Attune Medical. It received FDA 510(k) clearance on 2018-05-17 under approval number K180742. The device is classified under product code PLA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnsoETM?

EnsoETM is a medical device that received FDA 510(k) clearance on 2018-05-17. It is manufactured by Advanced Cooling Therapy, Inc. D/B/A Attune Medical. The 510(k) number is K180742.

When was EnsoETM approved by the FDA?

EnsoETM received FDA 510(k) clearance on 2018-05-17, under approval number K180742.

What company makes EnsoETM?

EnsoETM is manufactured by Advanced Cooling Therapy, Inc. D/B/A Attune Medical.

What is the FDA product code for EnsoETM?

The FDA product code for EnsoETM is PLA.

Other Devices by Advanced Cooling Therapy, Inc. D/B/A Attune Medical

K180244EnsoETM DEN230021ensoETM

Related Devices (Code: PLA)

K152450Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC K172493EnsoETMAttune Medical K170009Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K172029EnsoETMAttune Medical K233357EsoCool Thermal Regulation CatheterNuvaira, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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