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FDA 510(k)

MESI mTABLET SPIRO

K-Number: K251777 · 2026-03-02

ApplicantMesi D.O.O.
Decision Date2026-03-02
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MESI mTABLET SPIRO is a medical device manufactured by Mesi D.O.O.. It received FDA 510(k) clearance on 2026-03-02 under approval number K251777. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESI mTABLET SPIRO?

MESI mTABLET SPIRO is a medical device that received FDA 510(k) clearance on 2026-03-02. It is manufactured by Mesi D.O.O.. The 510(k) number is K251777.

When was MESI mTABLET SPIRO approved by the FDA?

MESI mTABLET SPIRO received FDA 510(k) clearance on 2026-03-02, under approval number K251777.

What company makes MESI mTABLET SPIRO?

MESI mTABLET SPIRO is manufactured by Mesi D.O.O..

What is the FDA product code for MESI mTABLET SPIRO?

The FDA product code for MESI mTABLET SPIRO is BZG.

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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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