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FDA 510(k)

FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)

K-Number: K121421 · 2013-01-17

ApplicantFresenius Medical Care North America, Design Cente
Decision Date2013-01-17
Product CodeONW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America, Design Cente. It received FDA 510(k) clearance on 2013-01-17 under 510(k) number K121421. 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 FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)?

FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) is a medical device that received FDA 510(k) clearance on 2013-01-17. The listed applicant is Fresenius Medical Care North America, Design Cente. The 510(k) number is K121421.

When did FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) receive FDA 510(k) clearance?

FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) received FDA 510(k) clearance on 2013-01-17, under 510(k) number K121421.

Who is the listed applicant for FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)?

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

What is the FDA product code for FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)?

The FDA product code for FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) is ONW.

Related Clinical Trials

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.

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Other records listing Fresenius Medical Care North America, Design Cente 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.

K123630FRESENIUS LIBERTY CYCLERK120823BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSK120505FRESENIUS 2008T HEMODIALYSIS MACHINEK101715FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

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.K1240352008K@HOME HEMODIALYSIS MACHINEFresenius Medical Care North AmericaK070049FRESENIUS 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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