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FDA 510(k)

EASY CARE AND TUBING SETS

K-Number: K994218 · 2000-02-10

ApplicantMedionics International, Inc.
Decision Date2000-02-10
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EASY CARE AND TUBING SETS is the device name listed in this FDA 510(k) record. The listed applicant is Medionics International, Inc.. It received FDA 510(k) clearance on 2000-02-10 under 510(k) number K994218. 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 EASY CARE AND TUBING SETS?

EASY CARE AND TUBING SETS is a medical device that received FDA 510(k) clearance on 2000-02-10. The listed applicant is Medionics International, Inc.. The 510(k) number is K994218.

When did EASY CARE AND TUBING SETS receive FDA 510(k) clearance?

EASY CARE AND TUBING SETS received FDA 510(k) clearance on 2000-02-10, under 510(k) number K994218.

Who is the listed applicant for EASY CARE AND TUBING SETS?

The FDA 510(k) record lists Medionics International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASY CARE AND TUBING SETS?

The FDA product code for EASY CARE AND TUBING SETS is FKX.

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Other records listing Medionics International, Inc. 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.

K130441FALLER STYLETK993149PERITONEAL DIALYSIS CATHETERS AND ADAPTERSK945567QC CAP

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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