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FDA 510(k)

FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

K-Number: K101715 · 2010-12-21

ApplicantFresenius Medical Care North America, Design Cente
Decision Date2010-12-21
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 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 2010-12-21 under 510(k) number K101715. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573?

FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is Fresenius Medical Care North America, Design Cente. The 510(k) number is K101715.

When did FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 receive FDA 510(k) clearance?

FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 received FDA 510(k) clearance on 2010-12-21, under 510(k) number K101715.

Who is the listed applicant for FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573?

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 2008T HEMODIALYSIS MACHINE MODEL 190573?

The FDA product code for FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 is KDI.

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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 CYCLERK121421FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)K120823BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSK120505FRESENIUS 2008T HEMODIALYSIS MACHINE

Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

Official Source

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

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