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FDA 510(k)

ACUTRON

K-Number: K211000 · 2022-06-09

ApplicantIlooda Co,., Ltd.
Decision Date2022-06-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUTRON is a medical device manufactured by Ilooda Co,., Ltd.. It received FDA 510(k) clearance on 2022-06-09 under approval number K211000. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUTRON?

ACUTRON is a medical device that received FDA 510(k) clearance on 2022-06-09. It is manufactured by Ilooda Co,., Ltd.. The 510(k) number is K211000.

When was ACUTRON approved by the FDA?

ACUTRON received FDA 510(k) clearance on 2022-06-09, under approval number K211000.

What company makes ACUTRON?

ACUTRON is manufactured by Ilooda Co,., Ltd..

What is the FDA product code for ACUTRON?

The FDA product code for ACUTRON is GEI.

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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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