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FDA 510(k)

FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR

K-Number: K070049 · 2011-02-03

ApplicantFresenius Medical Care North America
Decision Date2011-02-03
Product CodeONW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR 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 2011-02-03 under 510(k) number K070049. 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 WITH WIRELESS WETNESS DETECTOR?

FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR is a medical device that received FDA 510(k) clearance on 2011-02-03. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K070049.

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

FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR received FDA 510(k) clearance on 2011-02-03, under 510(k) number K070049.

Who is the listed applicant for FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR?

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 FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR?

The FDA product code for FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR 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 UNITSK1240352008K@HOME HEMODIALYSIS MACHINEK121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMK121599CRIT-LINE CLIP (CLIC)

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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.K1240352008K@HOME HEMODIALYSIS MACHINEFresenius Medical Care North AmericaK121421FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)Fresenius Medical Care North America, Design Cente

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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