FDA 510(k)

SMARTLOG DIABETES MANAGEMENT SOFTWARE

K-Number: K133346 · 2013-12-19

Decision Date2013-12-19

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SMARTLOG DIABETES 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 2013-12-19 under 510(k) number K133346. 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 SMARTLOG DIABETES MANAGEMENT SOFTWARE?

SMARTLOG DIABETES MANAGEMENT SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-12-19. The listed applicant is I-Sens, Inc.. The 510(k) number is K133346.

When did SMARTLOG DIABETES MANAGEMENT SOFTWARE receive FDA 510(k) clearance?

SMARTLOG DIABETES MANAGEMENT SOFTWARE received FDA 510(k) clearance on 2013-12-19, under 510(k) number K133346.

Who is the listed applicant for SMARTLOG DIABETES 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 SMARTLOG DIABETES MANAGEMENT SOFTWARE?

The FDA product code for SMARTLOG DIABETES 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.