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 a medical device manufactured by S.M.A.I.O. It received FDA 510(k) clearance on 2022-05-06 under approval 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. It is manufactured by S.M.A.I.O. The 510(k) number is K213975.
When was KEOPS Balance Analyzer 3D approved by the FDA?
KEOPS Balance Analyzer 3D received FDA 510(k) clearance on 2022-05-06, under approval number K213975.
What company makes KEOPS Balance Analyzer 3D?
KEOPS Balance Analyzer 3D is manufactured by S.M.A.I.O.
What is the FDA product code for KEOPS Balance Analyzer 3D?
The FDA product code for KEOPS Balance Analyzer 3D is LLZ.
Other Devices by S.M.A.I.O
Related Devices (Code: LLZ)
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.