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FDA 510(k)

TEST MODULE MODEL DM-352

K-Number: K781215 · 1978-08-31

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1978-08-31
Product Code
DecisionSubstantially Equivalent

Device Summary

TEST MODULE MODEL DM-352 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 1978-08-31 under 510(k) number K781215. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST MODULE MODEL DM-352?

TEST MODULE MODEL DM-352 is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K781215.

When did TEST MODULE MODEL DM-352 receive FDA 510(k) clearance?

TEST MODULE MODEL DM-352 received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781215.

Who is the listed applicant for TEST MODULE MODEL DM-352?

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

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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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