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FDA 510(k)

IXL DIABETES MANAGEMENT SYSTEM

K-Number: K031373 · 2003-12-19

ApplicantInsulet Corp.
Decision Date2003-12-19
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IXL DIABETES MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corp.. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K031373. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IXL DIABETES MANAGEMENT SYSTEM?

IXL DIABETES MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Insulet Corp.. The 510(k) number is K031373.

When did IXL DIABETES MANAGEMENT SYSTEM receive FDA 510(k) clearance?

IXL DIABETES MANAGEMENT SYSTEM received FDA 510(k) clearance on 2003-12-19, under 510(k) number K031373.

Who is the listed applicant for IXL DIABETES MANAGEMENT SYSTEM?

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

What is the FDA product code for IXL DIABETES MANAGEMENT SYSTEM?

The FDA product code for IXL DIABETES MANAGEMENT SYSTEM is LZG.

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Related Devices (Code: LZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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