COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200

Warmer, Thermal, Infusion Fluid

NXSTAGE MEDICAL, INC.

The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Comfortmate Fluid Warming System, Model # Fw-200; Comfortmate Disporsable Disposable Warming Set, Model #fws-200.

Pre-market Notification Details

Device IDK012832
510k NumberK012832
Device Name:COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200
ClassificationWarmer, Thermal, Infusion Fluid
Applicant NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
ContactKaren St. Onge
CorrespondentKaren St. Onge
NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
Product CodeLGZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-23
Decision Date2001-10-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.