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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 a medical device manufactured by Welch Allyn, Inc.. It received FDA 510(k) clearance on 2019-09-10 under approval 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. It is manufactured by Welch Allyn, Inc.. The 510(k) number is K191013.

When was Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option approved by the FDA?

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

What company makes Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option?

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option is manufactured by Welch Allyn, Inc..

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.

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Other Devices by Welch Allyn, Inc.

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Related Devices (Code: 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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