FDA 510(k)

BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR

K-Number: K041478 · 2004-10-28

Decision Date2004-10-28

Product CodeCGA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson. It received FDA 510(k) clearance on 2004-10-28 under 510(k) number K041478. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR?

BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR is a medical device that received FDA 510(k) clearance on 2004-10-28. The listed applicant is Becton Dickinson. The 510(k) number is K041478.

When did BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR receive FDA 510(k) clearance?

BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR received FDA 510(k) clearance on 2004-10-28, under 510(k) number K041478.

Who is the listed applicant for BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR?

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

What is the FDA product code for BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR?

The FDA product code for BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR is CGA.

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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.