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FDA 510(k)

FRESENIUS PD+ EXCHANGE DEVICE

K-Number: K915634 · 1993-07-01

ApplicantFresenius USA, Inc.
Decision Date1993-07-01
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FRESENIUS PD+ EXCHANGE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1993-07-01 under 510(k) number K915634. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS PD+ EXCHANGE DEVICE?

FRESENIUS PD+ EXCHANGE DEVICE is a medical device that received FDA 510(k) clearance on 1993-07-01. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K915634.

When did FRESENIUS PD+ EXCHANGE DEVICE receive FDA 510(k) clearance?

FRESENIUS PD+ EXCHANGE DEVICE received FDA 510(k) clearance on 1993-07-01, under 510(k) number K915634.

Who is the listed applicant for FRESENIUS PD+ EXCHANGE DEVICE?

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

What is the FDA product code for FRESENIUS PD+ EXCHANGE DEVICE?

The FDA product code for FRESENIUS PD+ EXCHANGE DEVICE is EKX.

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Other records listing Fresenius USA, 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.

K992275FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TSK970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXK974584FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSK973378C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61K9614652008H ON LINE CLEARANCE MONITORK955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

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Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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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