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FDA 510(k)

Athelas One

K-Number: K181288 · 2018-11-05

ApplicantAthelas, Inc.
Decision Date2018-11-05
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Athelas One is a medical device manufactured by Athelas, Inc.. It received FDA 510(k) clearance on 2018-11-05 under approval number K181288. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Athelas One?

Athelas One is a medical device that received FDA 510(k) clearance on 2018-11-05. It is manufactured by Athelas, Inc.. The 510(k) number is K181288.

When was Athelas One approved by the FDA?

Athelas One received FDA 510(k) clearance on 2018-11-05, under approval number K181288.

What company makes Athelas One?

Athelas One is manufactured by Athelas, Inc..

What is the FDA product code for Athelas One?

The FDA product code for Athelas One is GKZ.

Other Devices by Athelas, Inc.

K200828Athelas Home K243348Athelas Home

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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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