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FDA 510(k)

DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION

K-Number: K901477 · 1990-07-27

ApplicantDelmed, Inc.
Decision Date1990-07-27
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1990-07-27 under 510(k) number K901477. 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 DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION?

DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION is a medical device that received FDA 510(k) clearance on 1990-07-27. The listed applicant is Delmed, Inc.. The 510(k) number is K901477.

When did DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION receive FDA 510(k) clearance?

DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION received FDA 510(k) clearance on 1990-07-27, under 510(k) number K901477.

Who is the listed applicant for DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION?

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

What is the FDA product code for DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION?

The FDA product code for DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION is FKX.

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Other records listing Delmed, 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.

K895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERAK895142ENTERAL PUMP SET WITH ENTERAL SPIKEK895650ENTERAL PUMP SET W/ENTERA-FLO SPIKEK894506ENTERA-FLO ENTERAL FEEDING PUMPK901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONK900106CLOSED DISCONNECT SYSTEM

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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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