FDA 510(k)

CareSens S Fit Blood Glucose Monitoring System

K-Number: K180866 · 2018-08-31

Decision Date2018-08-31

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

CareSens S Fit Blood Glucose Monitoring System is a medical device manufactured by I-Sens, Inc.. It received FDA 510(k) clearance on 2018-08-31 under approval number K180866. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CareSens S Fit Blood Glucose Monitoring System?

CareSens S Fit Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-08-31. It is manufactured by I-Sens, Inc.. The 510(k) number is K180866.

When was CareSens S Fit Blood Glucose Monitoring System approved by the FDA?

CareSens S Fit Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-08-31, under approval number K180866.

What company makes CareSens S Fit Blood Glucose Monitoring System?

CareSens S Fit Blood Glucose Monitoring System is manufactured by I-Sens, Inc..

What is the FDA product code for CareSens S Fit Blood Glucose Monitoring System?

The FDA product code for CareSens S Fit Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Other Devices by I-Sens, Inc.

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Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.