The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Contour Next Usb Blood Glucose Monitoring System.
Device ID | K150942 |
510k Number | K150942 |
Device Name: | Contour Next USB Blood Glucose Monitoring System |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | BAYER HEALTHCARE DIABETES CARE 430 SOUTH BEIGER STREET Mishawaka, IN 46544 |
Contact | Jennifer L. Gregory |
Correspondent | Jennifer L. Gregory BAYER HEALTHCARE 430 South Beiger St. Mishawaka, IN 46544 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-08 |
Decision Date | 2015-11-25 |
Summary: | summary |