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FDA 510(k)

2008K@HOME HEMODIALYSIS MACHINE

K-Number: K124035 · 2013-07-03

ApplicantFresenius Medical Care North America
Decision Date2013-07-03
Product CodeONW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

2008K@HOME HEMODIALYSIS MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2013-07-03 under 510(k) number K124035. The device is classified under product code ONW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2008K@HOME HEMODIALYSIS MACHINE?

2008K@HOME HEMODIALYSIS MACHINE is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K124035.

When did 2008K@HOME HEMODIALYSIS MACHINE receive FDA 510(k) clearance?

2008K@HOME HEMODIALYSIS MACHINE received FDA 510(k) clearance on 2013-07-03, under 510(k) number K124035.

Who is the listed applicant for 2008K@HOME HEMODIALYSIS MACHINE?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2008K@HOME HEMODIALYSIS MACHINE?

The FDA product code for 2008K@HOME HEMODIALYSIS MACHINE is ONW.

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Other records listing Fresenius Medical Care North America as applicant

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.

K252181AquaAK162488Optiflux dialyzerK131611FRESENIUS DRY ACID DISSOLUTION UNITSK121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMK121599CRIT-LINE CLIP (CLIC)K120017FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM

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Related Devices (Code: ONW)

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.

K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)Quanta Dialysis Technologies, Ltd.K121421FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)Fresenius Medical Care North America, Design CenteK070049FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORFresenius Medical Care North America

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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