FDA 510(k) Application Details - K201493

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K201493
Device Name	Spirometer, Diagnostic
Applicant	MeHow Innovative Ltd Block A&B&C, NCBC Industrial Park, 6th Baolong Road, Longgang District Shenzhen 518116 CN Other 510(k) Applications for this Company
Contact	Gloria Sun Other 510(k) Applications for this Contact
Regulation Number	868.1840   More FDA Info for this Regulation Number
Classification Product Code	BZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2020
Decision Date	06/10/2021
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