PEARL DIABETES MANAGEMENT SYSTEM— 510(k) K100567

Name: FDA 510(k) clearance K100567
Creator: U.S. Food and Drug Administration
Published: 2011-05-10

Substantially Equivalent

M2 Group Holdings, Inc.

FDA 510(k) clearance K100567 for PEARL DIABETES MANAGEMENT SYSTEM, Substantially Equivalent on 2011-05-10. Applicant: M2 Group Holdings, Inc.. Device class: 2.

Clearance details

Applicant: M2 Group Holdings, Inc.
Product code: Code LZG
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2010-03-01
Decision date: 2011-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZG

product code LZG

Death: 104
Injury: 12,022
Malfunction: 135,004
Other: 1
Total: 147,131

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.