FDA 510(k)

ASCENSIA ELITE DIABETES CARE SYSTEM

K-Number: K043311 · 2004-12-22

Decision Date2004-12-22

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ASCENSIA ELITE DIABETES CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K043311. 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 ASCENSIA ELITE DIABETES CARE SYSTEM?

ASCENSIA ELITE DIABETES CARE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K043311.

When did ASCENSIA ELITE DIABETES CARE SYSTEM receive FDA 510(k) clearance?

ASCENSIA ELITE DIABETES CARE SYSTEM received FDA 510(k) clearance on 2004-12-22, under 510(k) number K043311.

Who is the listed applicant for ASCENSIA ELITE DIABETES CARE SYSTEM?

The FDA 510(k) record lists Bayer Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASCENSIA ELITE DIABETES CARE SYSTEM?

The FDA product code for ASCENSIA ELITE DIABETES CARE 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.