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FDA 510(k)

KEOPS Balance Analyzer 3D

K-Number: K213975 · 2022-05-06

ApplicantS.M.A.I.O
Decision Date2022-05-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KEOPS Balance Analyzer 3D is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K213975. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEOPS Balance Analyzer 3D?

KEOPS Balance Analyzer 3D is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is S.M.A.I.O. The 510(k) number is K213975.

When did KEOPS Balance Analyzer 3D receive FDA 510(k) clearance?

KEOPS Balance Analyzer 3D received FDA 510(k) clearance on 2022-05-06, under 510(k) number K213975.

Who is the listed applicant for KEOPS Balance Analyzer 3D?

The FDA 510(k) record lists S.M.A.I.O as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KEOPS Balance Analyzer 3D?

The FDA product code for KEOPS Balance Analyzer 3D is LLZ.

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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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