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FDA 510(k)

CareSens S Fit Blood Glucose Monitoring System

K-Number: K180866 · 2018-08-31

ApplicantI-Sens, Inc.
Decision Date2018-08-31
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CareSens S Fit Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is I-Sens, Inc.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) 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. The listed applicant is I-Sens, Inc.. The 510(k) number is K180866.

When did CareSens S Fit Blood Glucose Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for CareSens S Fit Blood Glucose Monitoring System?

The FDA 510(k) record lists I-Sens, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07296276Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DMRECRUITING

Other records listing I-Sens, Inc. as applicant

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Related Devices (Code: NBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.

Official Source

View on FDA Database →

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

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