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FDA 510(k)

ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K131419 · 2013-08-09

ApplicantI-Sens, Inc.
Decision Date2013-08-09
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACURA PLUS MULTI 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 2013-08-09 under 510(k) number K131419. 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 ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM?

ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-09. The listed applicant is I-Sens, Inc.. The 510(k) number is K131419.

When did ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2013-08-09, under 510(k) number K131419.

Who is the listed applicant for ACURA PLUS MULTI 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 ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM 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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