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FDA 510(k)

THERAPEUTIC EXCHANGE SYSTEM

K-Number: K831423 · 1984-01-03

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1984-01-03
Product CodeLQQ
DecisionSubstantially Equivalent

Device Summary

THERAPEUTIC EXCHANGE SYSTEM 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 1984-01-03 under 510(k) number K831423. The device is classified under product code LQQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPEUTIC EXCHANGE SYSTEM?

THERAPEUTIC EXCHANGE SYSTEM is a medical device that received FDA 510(k) clearance on 1984-01-03. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K831423.

When did THERAPEUTIC EXCHANGE SYSTEM receive FDA 510(k) clearance?

THERAPEUTIC EXCHANGE SYSTEM received FDA 510(k) clearance on 1984-01-03, under 510(k) number K831423.

Who is the listed applicant for THERAPEUTIC EXCHANGE SYSTEM?

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 THERAPEUTIC EXCHANGE SYSTEM?

The FDA product code for THERAPEUTIC EXCHANGE SYSTEM is LQQ.

Related Clinical Trials

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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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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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