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FDA 510(k)

NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100

K-Number: K013655 · 2002-02-04

ApplicantNxstage Medical, Inc.
Decision Date2002-02-04
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 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 2002-02-04 under 510(k) number K013655. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100?

NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 is a medical device that received FDA 510(k) clearance on 2002-02-04. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K013655.

When did NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 receive FDA 510(k) clearance?

NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 received FDA 510(k) clearance on 2002-02-04, under 510(k) number K013655.

Who is the listed applicant for NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100?

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 NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100?

The FDA product code for NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 is KPO.

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Other records listing Nxstage Medical, Inc. as applicant

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K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)K233213NxStage PureFlow SolutionK230632VersiHD with GuideMe softwareK183158NxStage Cartridge Express with SpeedswapK181991NxStage Connected Health SystemK171331NxStage System One

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Related Devices (Code: KPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedK253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC

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.

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