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FDA 510(k)

ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM

K-Number: K081318 · 2008-06-09

ApplicantLifescan, Inc.
Decision Date2008-06-09
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 2008-06-09 under 510(k) number K081318. 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 ZOOM DIABETES MANAGEMENT PROGRAM?

ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM is a medical device that received FDA 510(k) clearance on 2008-06-09. The listed applicant is Lifescan, Inc.. The 510(k) number is K081318.

When did ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM receive FDA 510(k) clearance?

ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM received FDA 510(k) clearance on 2008-06-09, under 510(k) number K081318.

Who is the listed applicant for ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM?

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 ZOOM DIABETES MANAGEMENT PROGRAM?

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

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Other records listing Lifescan, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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