FDA 510(k)

Asthma Monitor AM3

K-Number: K183479 · 2019-10-03

Decision Date2019-10-03

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Asthma Monitor AM3 is the device name listed in this FDA 510(k) record. The listed applicant is Eresearch Technology. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K183479. 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 Asthma Monitor AM3?

Asthma Monitor AM3 is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is Eresearch Technology. The 510(k) number is K183479.

When did Asthma Monitor AM3 receive FDA 510(k) clearance?

Asthma Monitor AM3 received FDA 510(k) clearance on 2019-10-03, under 510(k) number K183479.

Who is the listed applicant for Asthma Monitor AM3?

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

What is the FDA product code for Asthma Monitor AM3?

The FDA product code for Asthma Monitor AM3 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 K230501Spirobank OxiMir Medical International Research USA K230178EasyOne Sky SpirometerNdd Medizintechnik AG K222525Alveoair 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.