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FDA 510(k)

ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION

K-Number: K120558 · 2013-02-07

ApplicantLifescan, Inc.
Decision Date2013-02-07
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 2013-02-07 under 510(k) number K120558. 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 ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION?

ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION is a medical device that received FDA 510(k) clearance on 2013-02-07. The listed applicant is Lifescan, Inc.. The 510(k) number is K120558.

When did ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION receive FDA 510(k) clearance?

ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION received FDA 510(k) clearance on 2013-02-07, under 510(k) number K120558.

Who is the listed applicant for ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION?

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

What is the FDA product code for ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION?

The FDA product code for ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION is NBW. This falls under the OB/GYN category.

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Other records listing Lifescan, Inc. as applicant

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Related Devices (Code: NBW)

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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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