FDA 510(k)

MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM

K-Number: K040814 · 2004-04-15

Decision Date2004-04-15

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PRECISION XTRA ADVANCED DIABETES 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 2004-04-15 under 510(k) number K040814. 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 MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM?

MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-15. The listed applicant is Abbott Laboratories. The 510(k) number is K040814.

When did MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM received FDA 510(k) clearance on 2004-04-15, under 510(k) number K040814.

Who is the listed applicant for MODIFICATION TO PRECISION XTRA ADVANCED DIABETES 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 MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM?

The FDA product code for MODIFICATION TO PRECISION XTRA ADVANCED DIABETES 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.