FDA 510(k) Application Details - K221062

Device Classification Name	More FDA Info for this Device
510(K) Number	K221062
Device Name	RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
Applicant	Bionime Corporation No. 100, Section 2, Daqing Street., South District Taichung City 40242 TW Other 510(k) Applications for this Company
Contact	Yu Chi Huang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2022
Decision Date	09/26/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review