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FDA 510(k)

HEMODIALYSIS SYSTEM

K-Number: K813432 · 1982-06-23

ApplicantFhk
Decision Date1982-06-23
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fhk. It received FDA 510(k) clearance on 1982-06-23 under 510(k) number K813432. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMODIALYSIS SYSTEM?

HEMODIALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1982-06-23. The listed applicant is Fhk. The 510(k) number is K813432.

When did HEMODIALYSIS SYSTEM receive FDA 510(k) clearance?

HEMODIALYSIS SYSTEM received FDA 510(k) clearance on 1982-06-23, under 510(k) number K813432.

Who is the listed applicant for HEMODIALYSIS SYSTEM?

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

What is the FDA product code for HEMODIALYSIS SYSTEM?

The FDA product code for HEMODIALYSIS SYSTEM is FKP.

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Related Devices (Code: FKP)

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.

K181991NxStage Connected Health SystemNxstage Medical, Inc.K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.K040074ONEVIEW INTERFACENxstage Medical, Inc.K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North AmericaK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test Systems, Inc.

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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