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FDA 510(k)

NMC CYCLER MACHINE

K-Number: K905809 · 1992-02-25

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1992-02-25
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NMC CYCLER MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Care, Medical Products Div., Inc.. It received FDA 510(k) clearance on 1992-02-25 under 510(k) number K905809. 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 NMC CYCLER MACHINE?

NMC CYCLER MACHINE is a medical device that received FDA 510(k) clearance on 1992-02-25. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K905809.

When did NMC CYCLER MACHINE receive FDA 510(k) clearance?

NMC CYCLER MACHINE received FDA 510(k) clearance on 1992-02-25, under 510(k) number K905809.

Who is the listed applicant for NMC CYCLER MACHINE?

The FDA 510(k) record lists National Medical Care, Medical Products Div., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NMC CYCLER MACHINE?

The FDA product code for NMC CYCLER MACHINE is FKX.

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Other records listing National Medical Care, Medical Products Div., 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.

K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETK941757FORMALIN REUSE CARTK952343FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZERK930843RAPID DISCONNECT Y-SET, CAT. NO. 48-7000K914790HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-RK920697DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP

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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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