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FDA 510(k)

EnsoETM

K-Number: K172029 · 2018-01-05

ApplicantAttune Medical
Decision Date2018-01-05
Product CodePLA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnsoETM is a medical device manufactured by Attune Medical. It received FDA 510(k) clearance on 2018-01-05 under approval number K172029. 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 2018-01-05. It is manufactured by Attune Medical. The 510(k) number is K172029.

When was EnsoETM approved by the FDA?

EnsoETM received FDA 510(k) clearance on 2018-01-05, under approval number K172029.

What company makes EnsoETM?

EnsoETM is manufactured by Attune Medical.

What is the FDA product code for EnsoETM?

The FDA product code for EnsoETM is PLA.

Other Devices by Attune Medical

K172493EnsoETM

Related Devices (Code: PLA)

K152450Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC K172493EnsoETMAttune Medical K170009Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune 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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