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FDA 510(k)

Air Smart Extra Spirometer

K-Number: K222443 · 2023-08-09

ApplicantFeellife Health, Inc.
Decision Date2023-08-09
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Air Smart Extra Spirometer is the device name listed in this FDA 510(k) record. The listed applicant is Feellife Health, Inc.. It received FDA 510(k) clearance on 2023-08-09 under 510(k) number K222443. 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 Air Smart Extra Spirometer?

Air Smart Extra Spirometer is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Feellife Health, Inc.. The 510(k) number is K222443.

When did Air Smart Extra Spirometer receive FDA 510(k) clearance?

Air Smart Extra Spirometer received FDA 510(k) clearance on 2023-08-09, under 510(k) number K222443.

Who is the listed applicant for Air Smart Extra Spirometer?

The FDA 510(k) record lists Feellife Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air Smart Extra Spirometer?

The FDA product code for Air Smart Extra Spirometer is BZG.

Other records listing Feellife Health, Inc. as applicant

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.

K182906Portable Mesh Nebulizer

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 ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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