FDA 510(k)

FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM

K-Number: K890329 · 1989-05-11

Decision Date1989-05-11

Product CodeFIL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM 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 1989-05-11 under 510(k) number K890329. The device is classified under product code FIL. It was reviewed by the GU advisory panel. Product code FIL falls under the category of Radiology, which covers imaging devices and accessories used in diagnostic radiology. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM?

FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K890329.

When did FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM receive FDA 510(k) clearance?

FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM received FDA 510(k) clearance on 1989-05-11, under 510(k) number K890329.

Who is the listed applicant for FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM?

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 2008 BSS BEDSIDE DIALYSIS SYSTEM?

The FDA product code for FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM is FIL. This falls under the Radiology category.

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Other records listing Fresenius USA, Inc. as applicant

K992275FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS K970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX K974584FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS K973378C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 K9614652008H ON LINE CLEARANCE MONITOR K961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR

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Related Devices (Code: FIL)

K011741CRIT-LINE MONITOR III TQA (CLM TQA)Hemametrics K901038SPS 550-IPS (INTEGRATED PATIENT STATION)Baxter Healthcare Corp K790824REPGREEN ULTRAFILTRATION MONITORCyberex Corp.K781633ULTRAFILTRATION SCALEExtracorporeal Medical Specialities, Inc.K771875ULTRAFILTRATION MONITOR 5M9034Travenol Laboratories, S.A.K771227AK-10Gambro, 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.