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
40301937098503	K062058	000
40301937099500	K062058	000
00301937109010	K062058	000
50301937110011	K062058	000
50301937111018	K062058	000
40301939507102	K062058	000
40301939725254	K062058	000
40301939727210	K062058	000
40301937151017	K062058	000
40301937189010	K062058	000
40301939545012	K062058	000
40301937097506	K062058	000