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FDA 510(k)

CDS 2001 ARTIFICIAL KIDNEY

K-Number: K831376 · 1983-06-03

ApplicantElmar Medical Systems, Ltd.
Decision Date1983-06-03
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CDS 2001 ARTIFICIAL KIDNEY is the device name listed in this FDA 510(k) record. The listed applicant is Elmar Medical Systems, Ltd.. It received FDA 510(k) clearance on 1983-06-03 under 510(k) number K831376. 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 CDS 2001 ARTIFICIAL KIDNEY?

CDS 2001 ARTIFICIAL KIDNEY is a medical device that received FDA 510(k) clearance on 1983-06-03. The listed applicant is Elmar Medical Systems, Ltd.. The 510(k) number is K831376.

When did CDS 2001 ARTIFICIAL KIDNEY receive FDA 510(k) clearance?

CDS 2001 ARTIFICIAL KIDNEY received FDA 510(k) clearance on 1983-06-03, under 510(k) number K831376.

Who is the listed applicant for CDS 2001 ARTIFICIAL KIDNEY?

The FDA 510(k) record lists Elmar Medical Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDS 2001 ARTIFICIAL KIDNEY?

The FDA product code for CDS 2001 ARTIFICIAL KIDNEY is KOC.

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Related Devices (Code: KOC)

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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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