CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitorin

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 Blood Glucose Monitoring System, Contour® Next Usb Blood Glucose Monitoring System, Contour® Next One Blood Glucose Monitoring System, Contour® Next Ez Blood Glucose Monitoring System, Contour® Next Link Wireless Blood Glucose Monitorin.

Pre-market Notification Details

• Device ID: K191286
• 510k Number: K191286
• Device Name: CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitorin
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: Ascensia Diabetes Care 100 Summit Lake Drive Valhalla, NY 10595
• Contact: Stacie Geffner-atiya
• Correspondent: Stacie Geffner-atiya; Ascensia Diabetes Care 100 Summit Lake Drive Valhalla, NY 10595
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-13
• Decision Date: 2019-11-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40301937550155	K191286	000