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FDA 510(k)

IXL-II DIABETES MANAGEMENT SYSTEM

K-Number: K042792 · 2005-01-03

ApplicantInsulet Corporation
Decision Date2005-01-03
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IXL-II DIABETES MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2005-01-03 under 510(k) number K042792. 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-II DIABETES MANAGEMENT SYSTEM?

IXL-II DIABETES MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-01-03. The listed applicant is Insulet Corporation. The 510(k) number is K042792.

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

IXL-II DIABETES MANAGEMENT SYSTEM received FDA 510(k) clearance on 2005-01-03, under 510(k) number K042792.

Who is the listed applicant for IXL-II DIABETES MANAGEMENT SYSTEM?

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

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

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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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