FLEXWARMER, MODELS KZ-1 AND KZ-2— 510(k) K062644

Name: FDA 510(k) clearance K062644
Creator: U.S. Food and Drug Administration
Published: 2007-09-11

Substantially Equivalent

Merlyn Associates, Inc.

FDA 510(k) clearance K062644 for FLEXWARMER, MODELS KZ-1 AND KZ-2, Substantially Equivalent on 2007-09-11. Applicant: Merlyn Associates, Inc.. Device class: 2.

Clearance details

Applicant: Merlyn Associates, Inc.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2006-09-06
Decision date: 2007-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.