ENFLOW IV FLUID WARMER— 510(k) K112902

Substantially Equivalent

Vital Signs, Inc.

FDA 510(k) clearance K112902 for ENFLOW IV FLUID WARMER, Substantially Equivalent on 2012-03-14. Applicant: Vital Signs, Inc..

Clearance details

Applicant: Vital Signs, Inc.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2011-10-04
Decision date: 2012-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Totowa, NJ, US

Download summary PDF View on FDA.gov ↗

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.