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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 the device name listed in this FDA 510(k) record. The listed applicant is Mesi D.O.O.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) 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. The listed applicant is Mesi D.O.O.. The 510(k) number is K251777.

When did MESI mTABLET SPIRO receive FDA 510(k) clearance?

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

Who is the listed applicant for MESI mTABLET SPIRO?

The FDA 510(k) record lists Mesi D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESI mTABLET SPIRO?

The FDA product code for MESI mTABLET SPIRO is BZG.

Related Devices (Code: BZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private LimitedK222443Air Smart Extra SpirometerFeellife Health, Inc.

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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