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FDA 510(k)

FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD

K-Number: K844750 · 1985-02-15

ApplicantSeratronics, Inc.
Decision Date1985-02-15
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD is the device name listed in this FDA 510(k) record. The listed applicant is Seratronics, Inc.. It received FDA 510(k) clearance on 1985-02-15 under 510(k) number K844750. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD?

FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD is a medical device that received FDA 510(k) clearance on 1985-02-15. The listed applicant is Seratronics, Inc.. The 510(k) number is K844750.

When did FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD receive FDA 510(k) clearance?

FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD received FDA 510(k) clearance on 1985-02-15, under 510(k) number K844750.

Who is the listed applicant for FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD?

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 A2008 HEMODIALYSIS MACHINE EXPANSION MOD?

The FDA product code for FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD is FKQ.

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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: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal 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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