FDA 510(k)

ExoAtlet-II

K-Number: K201473 · 2021-07-16

Decision Date2021-07-16

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

ExoAtlet-II is the device name listed in this FDA 510(k) record. The listed applicant is Exoatlet Asia Co. , Ltd.. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K201473. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ExoAtlet-II?

ExoAtlet-II is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Exoatlet Asia Co. , Ltd.. The 510(k) number is K201473.

When did ExoAtlet-II receive FDA 510(k) clearance?

ExoAtlet-II received FDA 510(k) clearance on 2021-07-16, under 510(k) number K201473.

Who is the listed applicant for ExoAtlet-II?

The FDA 510(k) record lists Exoatlet Asia Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ExoAtlet-II?

The FDA product code for ExoAtlet-II is PHL.

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Official Source

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