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FDA 510(k)

FRESENIUS LIBERTY CYCLER

K-Number: K123630 · 2013-09-09

ApplicantFresenius Medical Care North America, Design Cente
Decision Date2013-09-09
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS LIBERTY CYCLER 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 2013-09-09 under 510(k) number K123630. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS LIBERTY CYCLER?

FRESENIUS LIBERTY CYCLER is a medical device that received FDA 510(k) clearance on 2013-09-09. The listed applicant is Fresenius Medical Care North America, Design Cente. The 510(k) number is K123630.

When did FRESENIUS LIBERTY CYCLER receive FDA 510(k) clearance?

FRESENIUS LIBERTY CYCLER received FDA 510(k) clearance on 2013-09-09, under 510(k) number K123630.

Who is the listed applicant for FRESENIUS LIBERTY CYCLER?

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 LIBERTY CYCLER?

The FDA product code for FRESENIUS LIBERTY CYCLER is FKX.

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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.

K121421FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)K120823BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSK120505FRESENIUS 2008T HEMODIALYSIS MACHINEK101715FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

Related Devices (Code: FKX)

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.

K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath

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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