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FDA 510(k)

THE AMP 80/2 PEDIATRIC CYCLER SYSTEM

K-Number: K811986 · 1981-08-31

ApplicantAmerican Medical Products, Inc.
Decision Date1981-08-31
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE AMP 80/2 PEDIATRIC CYCLER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Products, Inc.. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K811986. 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 THE AMP 80/2 PEDIATRIC CYCLER SYSTEM?

THE AMP 80/2 PEDIATRIC CYCLER SYSTEM is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is American Medical Products, Inc.. The 510(k) number is K811986.

When did THE AMP 80/2 PEDIATRIC CYCLER SYSTEM receive FDA 510(k) clearance?

THE AMP 80/2 PEDIATRIC CYCLER SYSTEM received FDA 510(k) clearance on 1981-08-31, under 510(k) number K811986.

Who is the listed applicant for THE AMP 80/2 PEDIATRIC CYCLER SYSTEM?

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

What is the FDA product code for THE AMP 80/2 PEDIATRIC CYCLER SYSTEM?

The FDA product code for THE AMP 80/2 PEDIATRIC CYCLER SYSTEM is FKX.

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Other records listing American Medical Products, 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.

K922290SINGLE-STEP PREGNANCY, HCG TESTK862221E-Z CLEANK861251AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011NK830881AMPERCIDE DISINFECTANT ACCESSORY TO -K823827AMP 80/2 OUTFLOW MONITOR MODIFICATIONK822543CAPD SAFE LOCK TRANSFER SET

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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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