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FDA 510(k)

EXTRACORPOREAL'S EXP 400 PARALLEL PLATE

K-Number: K802364 · 1981-01-29

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1981-01-29
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL'S EXP 400 PARALLEL PLATE 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 1981-01-29 under 510(k) number K802364. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRACORPOREAL'S EXP 400 PARALLEL PLATE?

EXTRACORPOREAL'S EXP 400 PARALLEL PLATE is a medical device that received FDA 510(k) clearance on 1981-01-29. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K802364.

When did EXTRACORPOREAL'S EXP 400 PARALLEL PLATE receive FDA 510(k) clearance?

EXTRACORPOREAL'S EXP 400 PARALLEL PLATE received FDA 510(k) clearance on 1981-01-29, under 510(k) number K802364.

Who is the listed applicant for EXTRACORPOREAL'S EXP 400 PARALLEL PLATE?

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 EXTRACORPOREAL'S EXP 400 PARALLEL PLATE?

The FDA product code for EXTRACORPOREAL'S EXP 400 PARALLEL PLATE is FJG.

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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: FJG)

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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