QWIK-1(TM) IN-LINE IV FLUID WARMER— 510(k) K914867

Substantially Equivalent

Microwave Medical Systems, Inc.

FDA 510(k) clearance K914867 for QWIK-1(TM) IN-LINE IV FLUID WARMER, Substantially Equivalent on 1992-10-23. Applicant: Microwave Medical Systems, Inc..

Clearance details

Applicant: Microwave Medical Systems, Inc.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 1991-10-29
Decision date: 1992-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, MA, 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.