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FDA 510(k)

COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION

K-Number: K103396 · 2011-09-27

ApplicantI-Sens, Inc.
Decision Date2011-09-27
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION 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 2011-09-27 under 510(k) number K103396. 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 COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION?

COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION is a medical device that received FDA 510(k) clearance on 2011-09-27. The listed applicant is I-Sens, Inc.. The 510(k) number is K103396.

When did COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION receive FDA 510(k) clearance?

COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION received FDA 510(k) clearance on 2011-09-27, under 510(k) number K103396.

Who is the listed applicant for COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION?

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 COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION?

The FDA product code for COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION is NBW. This falls under the OB/GYN category.

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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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