FDA 510(k)

Spirobank Oxi

K-Number: K230501 · 2023-12-15

ApplicantMir Medical International Research USA

Decision Date2023-12-15

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Spirobank Oxi is the device name listed in this FDA 510(k) record. The listed applicant is Mir Medical International Research USA. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K230501. 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 Spirobank Oxi?

Spirobank Oxi is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Mir Medical International Research USA. The 510(k) number is K230501.

When did Spirobank Oxi receive FDA 510(k) clearance?

Spirobank Oxi received FDA 510(k) clearance on 2023-12-15, under 510(k) number K230501.

Who is the listed applicant for Spirobank Oxi?

The FDA 510(k) record lists Mir Medical International Research USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spirobank Oxi?

The FDA product code for Spirobank Oxi 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.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair AB K230178EasyOne Sky SpirometerNdd Medizintechnik AG K222525Alveoair Digital SpirometerRoundworks Technologies Private Limited K222443Air 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.