FDA 510(k) Application Details - K222443

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K222443
Device Name	Spirometer, Diagnostic
Applicant	FeelLife Health Inc. Room 1903, Building A, No.9 Furong Road, Tantou Community Songgang Subdistrict, BaoÆan District Shenzhen 518104 CN Other 510(k) Applications for this Company
Contact	May Xiao 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	08/12/2022
Decision Date	08/09/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review