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FDA 510(k)

AMIA AUTOMATED PD SYSTEM

K-Number: K124018 · 2013-06-14

ApplicantDeka Research & Development Corp.
Decision Date2013-06-14
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMIA AUTOMATED PD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research & Development Corp.. It received FDA 510(k) clearance on 2013-06-14 under 510(k) number K124018. 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 AMIA AUTOMATED PD SYSTEM?

AMIA AUTOMATED PD SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-14. The listed applicant is Deka Research & Development Corp.. The 510(k) number is K124018.

When did AMIA AUTOMATED PD SYSTEM receive FDA 510(k) clearance?

AMIA AUTOMATED PD SYSTEM received FDA 510(k) clearance on 2013-06-14, under 510(k) number K124018.

Who is the listed applicant for AMIA AUTOMATED PD SYSTEM?

The FDA 510(k) record lists Deka Research & Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMIA AUTOMATED PD SYSTEM?

The FDA product code for AMIA AUTOMATED PD SYSTEM is FKX.

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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

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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