FDA 510(k) Application Details - K221349

Device Classification Name	More FDA Info for this Device
510(K) Number	K221349
Device Name	XPER Technology PREMIUM Pro Blood Glucose Monitoring System
Applicant	TaiDoc Technology Corporation B1-7F, No.127, Wugong 2nd Rd., Wugu District New Taipei City 24888 TW Other 510(k) Applications for this Company
Contact	Jacky Chou Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2022
Decision Date	11/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review