ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080

System, Test, Blood Glucose, Over The Counter

BAYER HEALTHCARE

The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080.

Pre-market Notification Details

• Device ID: K062058
• 510k Number: K062058
• Device Name: ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544
• Contact: Roger Sonnenberg
• Correspondent: Roger Sonnenberg; BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-20
• Decision Date: 2006-09-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40301939556018	K062058	000
40301939545012	K062058	000
40301937189010	K062058	000
40301937151017	K062058	000
40301939727210	K062058	000
40301939725254	K062058	000