Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FRESENIUS 2008T HEMODIALYSIS MACHINE

K-Number: K120505 · 2012-03-06

ApplicantFresenius Medical Care North America, Design Cente
Decision Date2012-03-06
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS 2008T HEMODIALYSIS MACHINE 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 2012-03-06 under 510(k) number K120505. 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?

FRESENIUS 2008T HEMODIALYSIS MACHINE is a medical device that received FDA 510(k) clearance on 2012-03-06. The listed applicant is Fresenius Medical Care North America, Design Cente. The 510(k) number is K120505.

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

FRESENIUS 2008T HEMODIALYSIS MACHINE received FDA 510(k) clearance on 2012-03-06, under 510(k) number K120505.

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

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?

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

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 PROTECTORSK101715FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

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.

↑