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FDA 510(k)

COIL DIALYSIS, MODELS DM-360 AND DM-360-

K-Number: K790382 · 1979-05-02

ApplicantEstracorporeal, Inc.
Decision Date1979-05-02
Product CodeFKD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COIL DIALYSIS, MODELS DM-360 AND DM-360- is the device name listed in this FDA 510(k) record. The listed applicant is Estracorporeal, Inc.. It received FDA 510(k) clearance on 1979-05-02 under 510(k) number K790382. The device is classified under product code FKD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COIL DIALYSIS, MODELS DM-360 AND DM-360-?

COIL DIALYSIS, MODELS DM-360 AND DM-360- is a medical device that received FDA 510(k) clearance on 1979-05-02. The listed applicant is Estracorporeal, Inc.. The 510(k) number is K790382.

When did COIL DIALYSIS, MODELS DM-360 AND DM-360- receive FDA 510(k) clearance?

COIL DIALYSIS, MODELS DM-360 AND DM-360- received FDA 510(k) clearance on 1979-05-02, under 510(k) number K790382.

Who is the listed applicant for COIL DIALYSIS, MODELS DM-360 AND DM-360-?

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

What is the FDA product code for COIL DIALYSIS, MODELS DM-360 AND DM-360-?

The FDA product code for COIL DIALYSIS, MODELS DM-360 AND DM-360- is FKD.

Related Clinical Trials

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Other records listing Estracorporeal, 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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