FDA 510(k)

PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM

K-Number: K040628 · 2004-03-25

Decision Date2004-03-25

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2004-03-25 under 510(k) number K040628. 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 PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM?

PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-25. The listed applicant is Abbott Laboratories. The 510(k) number is K040628.

When did PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 2004-03-25, under 510(k) number K040628.

Who is the listed applicant for PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM?

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

What is the FDA product code for PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM?

The FDA product code for PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM 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.