FDA 510(k) Application Details - K202062

Device Classification Name	More FDA Info for this Device
510(K) Number	K202062
Device Name	wheezo WheezeRate Detector
Applicant	Respiri Limited Level 10, 446 Collins Street Melbourne 3000 AU Other 510(k) Applications for this Company
Contact	Samaneh Sarraf Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2020
Decision Date	03/11/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review