COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200— 510(k) K012832

Substantially Equivalent

Nxstage Medical, Inc.

FDA 510(k) clearance K012832 for COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200, Substantially Equivalent on 2001-10-24. Applicant: Nxstage Medical, Inc..

Clearance details

Applicant: Nxstage Medical, Inc.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2001-08-23
Decision date: 2001-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrence, 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.