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FDA 510(k)

EXP* 700 PARALLEL PLATE DIALYZER

K-Number: K840146 · 1984-02-04

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1984-02-04
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXP* 700 PARALLEL PLATE DIALYZER 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 1984-02-04 under 510(k) number K840146. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXP* 700 PARALLEL PLATE DIALYZER?

EXP* 700 PARALLEL PLATE DIALYZER is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K840146.

When did EXP* 700 PARALLEL PLATE DIALYZER receive FDA 510(k) clearance?

EXP* 700 PARALLEL PLATE DIALYZER received FDA 510(k) clearance on 1984-02-04, under 510(k) number K840146.

Who is the listed applicant for EXP* 700 PARALLEL PLATE DIALYZER?

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 EXP* 700 PARALLEL PLATE DIALYZER?

The FDA product code for EXP* 700 PARALLEL PLATE DIALYZER is KOC.

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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 DIALYZERK832547ULTRAFILTRATION CONTROLLERK831423THERAPEUTIC EXCHANGE SYSTEM

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Related Devices (Code: KOC)

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.

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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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