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FDA 510(k)

PEARL DIABETES MANAGEMENT SYSTEM

K-Number: K100567 · 2011-05-10

ApplicantM2 Group Holdings, Inc.
Decision Date2011-05-10
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PEARL DIABETES MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is M2 Group Holdings, Inc.. It received FDA 510(k) clearance on 2011-05-10 under 510(k) number K100567. 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 PEARL DIABETES MANAGEMENT SYSTEM?

PEARL DIABETES MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-10. The listed applicant is M2 Group Holdings, Inc.. The 510(k) number is K100567.

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

PEARL DIABETES MANAGEMENT SYSTEM received FDA 510(k) clearance on 2011-05-10, under 510(k) number K100567.

Who is the listed applicant for PEARL DIABETES MANAGEMENT SYSTEM?

The FDA 510(k) record lists M2 Group Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: LZG)

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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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