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FDA 510(k)

Spirometer

K-Number: K201493 · 2021-06-10

ApplicantMehow Innovative, Ltd.
Decision Date2021-06-10
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Spirometer is a medical device manufactured by Mehow Innovative, Ltd.. It received FDA 510(k) clearance on 2021-06-10 under approval number K201493. 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 Spirometer?

Spirometer is a medical device that received FDA 510(k) clearance on 2021-06-10. It is manufactured by Mehow Innovative, Ltd.. The 510(k) number is K201493.

When was Spirometer approved by the FDA?

Spirometer received FDA 510(k) clearance on 2021-06-10, under approval number K201493.

What company makes Spirometer?

Spirometer is manufactured by Mehow Innovative, Ltd..

What is the FDA product code for Spirometer?

The FDA product code for Spirometer 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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