wheezo WheezeRate Detector— 510(k) K202062

Substantially Equivalent

Respiri Limited

FDA 510(k) clearance K202062 for wheezo WheezeRate Detector, Substantially Equivalent on 2021-03-11. Applicant: Respiri Limited.

Clearance details

Applicant: Respiri Limited
Product code: Code PHZ
Advisory panel: Anesthesiology
Date received: 2020-07-27
Decision date: 2021-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

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Data sourced from openFDA. This site is unofficial and independent of the FDA.