FORA G20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

TaiDoc Technology Corporation

The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora G20 Blood Glucose Monitoring System, U-rught Td-4252d Blood Glucose Monitoring System.

Pre-market Notification Details

• Device ID: K101631
• 510k Number: K101631
• Device Name: FORA G20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888
• Contact: Teling Hsu
• Correspondent: Teling Hsu; TaiDoc Technology Corporation 3F, 5F, NO 127 WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888
• Product Code: NBW
• Subsequent Product Code: JJX
• Subsequent Product Code: LFR
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-06-10
• Decision Date: 2011-09-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816042010828	K101631	000
00816042010804	K101631	000
80816042013887	K101631	000