Contour® Next GEN Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

Ascensia Diabetes Care

The following data is part of a premarket notification filed by Ascensia Diabetes Care with the FDA for Contour® Next Gen Blood Glucose Monitoring System.

Pre-market Notification Details

• Device ID: K193407
• 510k Number: K193407
• Device Name: Contour® Next GEN Blood Glucose Monitoring System
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: Ascensia Diabetes Care 100 Summit Lake Drive Valhalla, NY 10595
• Contact: Colleen Burdel
• Correspondent: Colleen Burdel; Ascensia Diabetes Care 100 Summit Lake Drive Valhalla, NY 10595
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-09
• Decision Date: 2021-12-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00301933537015	K193407	000
00301933536018	K193407	000
40301939658019	K193407	000
40301937383012	K193407	000
00301937917011	K193407	000