QiF Blood and Fluid Warmer— 510(k) K163708

Substantially Equivalent

Quality IN Flow , Ltd.

FDA 510(k) clearance K163708 for QiF Blood and Fluid Warmer, Substantially Equivalent on 2017-04-20. Applicant: Quality IN Flow , Ltd..

Clearance details

Applicant: Quality IN Flow , Ltd.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2016-12-29
Decision date: 2017-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Kibutz Einat, IL

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.