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FDA 510(k)

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option

K-Number: K191013 · 2019-09-10

ApplicantWelch Allyn, Inc.
Decision Date2019-09-10
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2019-09-10 under 510(k) number K191013. 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 Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option?

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option is a medical device that received FDA 510(k) clearance on 2019-09-10. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K191013.

When did Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option receive FDA 510(k) clearance?

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option received FDA 510(k) clearance on 2019-09-10, under 510(k) number K191013.

Who is the listed applicant for Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option?

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

What is the FDA product code for Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option?

The FDA product code for Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option is BZG.

Other records listing Welch Allyn, Inc. as applicant

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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

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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