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FDA 510(k)

FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM

K-Number: K121341 · 2012-12-06

ApplicantFresenius Medical Care North America
Decision Date2012-12-06
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM 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 2012-12-06 under 510(k) number K121341. 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 WITH BIBAG SYSTEM?

FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-06. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K121341.

When did FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM receive FDA 510(k) clearance?

FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM received FDA 510(k) clearance on 2012-12-06, under 510(k) number K121341.

Who is the listed applicant for FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM?

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 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM?

The FDA product code for FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM is KDI.

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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 MACHINEK121599CRIT-LINE CLIP (CLIC)K120017FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM

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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

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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