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FDA 510(k)

MonoStereo

K-Number: K234096 · 2024-09-19

ApplicantMedicaltek Co., Ltd.
Decision Date2024-09-19
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MonoStereo is a medical device manufactured by Medicaltek Co., Ltd.. It received FDA 510(k) clearance on 2024-09-19 under approval number K234096. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MonoStereo?

MonoStereo is a medical device that received FDA 510(k) clearance on 2024-09-19. It is manufactured by Medicaltek Co., Ltd.. The 510(k) number is K234096.

When was MonoStereo approved by the FDA?

MonoStereo received FDA 510(k) clearance on 2024-09-19, under approval number K234096.

What company makes MonoStereo?

MonoStereo is manufactured by Medicaltek Co., Ltd..

What is the FDA product code for MonoStereo?

The FDA product code for MonoStereo is EOB.

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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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