EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120— 510(k) K060537

Substantially Equivalent

Enginivity, LLC

FDA 510(k) clearance K060537 for EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120, Substantially Equivalent on 2006-06-08. Applicant: Enginivity, LLC.

Clearance details

Applicant: Enginivity, LLC
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2006-02-28
Decision date: 2006-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kittery, ME, US

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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.