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FDA 510(k)

TytoCare Lung Sounds Analyzer

K-Number: K221614 · 2023-02-24

ApplicantTyto Care , Ltd.
Decision Date2023-02-24
Product CodePHZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TytoCare Lung Sounds Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Tyto Care , Ltd.. It received FDA 510(k) clearance on 2023-02-24 under 510(k) number K221614. The device is classified under product code PHZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TytoCare Lung Sounds Analyzer?

TytoCare Lung Sounds Analyzer is a medical device that received FDA 510(k) clearance on 2023-02-24. The listed applicant is Tyto Care , Ltd.. The 510(k) number is K221614.

When did TytoCare Lung Sounds Analyzer receive FDA 510(k) clearance?

TytoCare Lung Sounds Analyzer received FDA 510(k) clearance on 2023-02-24, under 510(k) number K221614.

Who is the listed applicant for TytoCare Lung Sounds Analyzer?

The FDA 510(k) record lists Tyto Care , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TytoCare Lung Sounds Analyzer?

The FDA product code for TytoCare Lung Sounds Analyzer is PHZ.

Other records listing Tyto Care , Ltd. 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.

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Related Devices (Code: PHZ)

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.

K252844Tyto Insights for Wheeze Detection (with PCCP)Tyto Care , Ltd.K243567Tyto Insights for Rhonchi DetectionTyto Care , Ltd.K240555Tyto Insights for Crackles DetectionTyto Care , Ltd.K232237Tyto Insights for Wheeze DetectionTyto Care , Ltd.K202062wheezo WheezeRate DetectorRespiri 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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