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FDA 510(k)

PATIENT AID, MODEL DM-351

K-Number: K781176 · 1978-09-07

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1978-09-07
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PATIENT AID, MODEL DM-351 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 1978-09-07 under 510(k) number K781176. 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 PATIENT AID, MODEL DM-351?

PATIENT AID, MODEL DM-351 is a medical device that received FDA 510(k) clearance on 1978-09-07. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K781176.

When did PATIENT AID, MODEL DM-351 receive FDA 510(k) clearance?

PATIENT AID, MODEL DM-351 received FDA 510(k) clearance on 1978-09-07, under 510(k) number K781176.

Who is the listed applicant for PATIENT AID, MODEL DM-351?

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 PATIENT AID, MODEL DM-351?

The FDA product code for PATIENT AID, MODEL DM-351 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.

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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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