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FDA 510(k)

MODEL DM-333 DIALYSIS CONTROL STATION

K-Number: K811444 · 1981-06-23

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1981-06-23
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL DM-333 DIALYSIS CONTROL STATION is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1981-06-23 under 510(k) number K811444. 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 MODEL DM-333 DIALYSIS CONTROL STATION?

MODEL DM-333 DIALYSIS CONTROL STATION is a medical device that received FDA 510(k) clearance on 1981-06-23. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K811444.

When did MODEL DM-333 DIALYSIS CONTROL STATION receive FDA 510(k) clearance?

MODEL DM-333 DIALYSIS CONTROL STATION received FDA 510(k) clearance on 1981-06-23, under 510(k) number K811444.

Who is the listed applicant for MODEL DM-333 DIALYSIS CONTROL STATION?

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

What is the FDA product code for MODEL DM-333 DIALYSIS CONTROL STATION?

The FDA product code for MODEL DM-333 DIALYSIS CONTROL STATION is FKQ.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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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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