FDA 510(k)

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

K-Number: K012832 · 2001-10-24

Decision Date2001-10-24

Product CodeLGZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 is the device name listed in this FDA 510(k) record. The listed applicant is Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2001-10-24 under 510(k) number K012832. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200?

COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K012832.

When did COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 receive FDA 510(k) clearance?

COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 received FDA 510(k) clearance on 2001-10-24, under 510(k) number K012832.

Who is the listed applicant for COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200?

The FDA 510(k) record lists Nxstage Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200?

The FDA product code for COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 is LGZ.

Related Clinical Trials

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Other records listing Nxstage Medical, Inc. as applicant

K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)K233213NxStage PureFlow Solution K230632VersiHD with GuideMe software K183158NxStage Cartridge Express with Speedswap K181991NxStage Connected Health System K171331NxStage System One

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Related Devices (Code: LGZ)

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical K260988°M Warmer System with °M StationMequ A/S K252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/S K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.