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FDA 510(k)

FRESENIUS HEMOFLOW F80 DIALYZER

K-Number: K861106 · 1986-04-07

ApplicantSeratronics, Inc.
Decision Date1986-04-07
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS HEMOFLOW F80 DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Seratronics, Inc.. It received FDA 510(k) clearance on 1986-04-07 under 510(k) number K861106. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS HEMOFLOW F80 DIALYZER?

FRESENIUS HEMOFLOW F80 DIALYZER is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Seratronics, Inc.. The 510(k) number is K861106.

When did FRESENIUS HEMOFLOW F80 DIALYZER receive FDA 510(k) clearance?

FRESENIUS HEMOFLOW F80 DIALYZER received FDA 510(k) clearance on 1986-04-07, under 510(k) number K861106.

Who is the listed applicant for FRESENIUS HEMOFLOW F80 DIALYZER?

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

What is the FDA product code for FRESENIUS HEMOFLOW F80 DIALYZER?

The FDA product code for FRESENIUS HEMOFLOW F80 DIALYZER is KDI.

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Other records listing Seratronics, 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.

K955299DPS 4 DIALYZER PREPARATION SYSTEMK931336DRS 4 DIALYZER REPROCESSING SYSTEMK944539DRS 4 ND DIALYZER REPROCESSING SYSTEMK923529DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCESK914580DRS-4 DIALYZER REPROCESSING SYSTEMK874573FRESENIUS PURISTERIL 340 (TM)

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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