EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM

System, Test, Blood Glucose, Over The Counter

EPS BIO TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Eps Bio Technology Corp. with the FDA for Easymax V Self Monitoring Blood Glucose System.

Pre-market Notification Details

• Device ID: K092894
• 510k Number: K092894
• Device Name: EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: EPS BIO TECHNOLOGY CORP. 2 F,NO. 49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City, TW 30071
• Contact: Y.c. Lei
• Correspondent: Y.c. Lei; EPS BIO TECHNOLOGY CORP. 2 F,NO. 49-2, LANE 2, SEC. 2, GUANG FU ROAD Hsinchu City, TW 30071
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-09-21
• Decision Date: 2010-02-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885017000058	K092894	000