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 a medical device manufactured by Respiri Limited. It received FDA 510(k) clearance on 2021-03-11 under approval 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. It is manufactured by Respiri Limited. The 510(k) number is K202062.
When was wheezo WheezeRate Detector approved by the FDA?
wheezo WheezeRate Detector received FDA 510(k) clearance on 2021-03-11, under approval number K202062.
What company makes wheezo WheezeRate Detector?
wheezo WheezeRate Detector is manufactured by Respiri Limited.
What is the FDA product code for wheezo WheezeRate Detector?
The FDA product code for wheezo WheezeRate Detector is PHZ.
Related Devices (Code: PHZ)
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.