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FDA 510(k)

ELLAVI UBT

K-Number: K230849 · 2023-11-13

ApplicantSinapi Biomedical (Pty) , Ltd.
Decision Date2023-11-13
Product CodeOQY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ELLAVI UBT is a medical device manufactured by Sinapi Biomedical (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-11-13 under approval number K230849. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELLAVI UBT?

ELLAVI UBT is a medical device that received FDA 510(k) clearance on 2023-11-13. It is manufactured by Sinapi Biomedical (Pty) , Ltd.. The 510(k) number is K230849.

When was ELLAVI UBT approved by the FDA?

ELLAVI UBT received FDA 510(k) clearance on 2023-11-13, under approval number K230849.

What company makes ELLAVI UBT?

ELLAVI UBT is manufactured by Sinapi Biomedical (Pty) , Ltd..

What is the FDA product code for ELLAVI UBT?

The FDA product code for ELLAVI UBT is OQY.

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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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