FDA 510(k)

PARADIGM LINK BLOOD GLUCOSE METER

K-Number: K040603 · 2004-05-19

Decision Date2004-05-19

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PARADIGM LINK BLOOD GLUCOSE METER is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2004-05-19 under 510(k) number K040603. 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 PARADIGM LINK BLOOD GLUCOSE METER?

PARADIGM LINK BLOOD GLUCOSE METER is a medical device that received FDA 510(k) clearance on 2004-05-19. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K040603.

When did PARADIGM LINK BLOOD GLUCOSE METER receive FDA 510(k) clearance?

PARADIGM LINK BLOOD GLUCOSE METER received FDA 510(k) clearance on 2004-05-19, under 510(k) number K040603.

Who is the listed applicant for PARADIGM LINK BLOOD GLUCOSE METER?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARADIGM LINK BLOOD GLUCOSE METER?

The FDA product code for PARADIGM LINK BLOOD GLUCOSE METER is NBW. This falls under the OB/GYN category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.