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FDA 510(k)

wheezo WheezeRate Detector

K-Number: K202062 · 2021-03-11

ApplicantRespiri Limited
Decision Date2021-03-11
Product CodePHZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

wheezo WheezeRate Detector is the device name listed in this FDA 510(k) record. The listed applicant is Respiri Limited. It received FDA 510(k) clearance on 2021-03-11 under 510(k) number K202062. 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 wheezo WheezeRate Detector?

wheezo WheezeRate Detector is a medical device that received FDA 510(k) clearance on 2021-03-11. The listed applicant is Respiri Limited. The 510(k) number is K202062.

When did wheezo WheezeRate Detector receive FDA 510(k) clearance?

wheezo WheezeRate Detector received FDA 510(k) clearance on 2021-03-11, under 510(k) number K202062.

Who is the listed applicant for wheezo WheezeRate Detector?

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

What is the FDA product code for wheezo WheezeRate Detector?

The FDA product code for wheezo WheezeRate Detector is PHZ.

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.K221614TytoCare Lung Sounds AnalyzerTyto Care , Ltd.

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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