510(k) K121775— ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER

Substantially Equivalent

Vital Signs, Inc., A GE Healthcare Company

Clearance details

Applicant: Vital Signs, Inc., A GE Healthcare Company
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2012-06-18
Decision date: 2012-11-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Totowa, NJ, US

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.