FDA 510(k)

PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE

K-Number: K100937 · 2010-12-21

Decision Date2010-12-21

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE 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 2010-12-21 under 510(k) number K100937. 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 PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE?

PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is I-Sens, Inc.. The 510(k) number is K100937.

When did PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE receive FDA 510(k) clearance?

PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE received FDA 510(k) clearance on 2010-12-21, under 510(k) number K100937.

Who is the listed applicant for PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE?

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 PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE?

The FDA product code for PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE 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.