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FDA 510(k)

SUITCASE KIDNEY HEMODIALYSIS SYSTEM

K-Number: K781405 · 1978-12-07

ApplicantUnion Carbide Corp.
Decision Date1978-12-07
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUITCASE KIDNEY HEMODIALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1978-12-07 under 510(k) number K781405. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUITCASE KIDNEY HEMODIALYSIS SYSTEM?

SUITCASE KIDNEY HEMODIALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1978-12-07. The listed applicant is Union Carbide Corp.. The 510(k) number is K781405.

When did SUITCASE KIDNEY HEMODIALYSIS SYSTEM receive FDA 510(k) clearance?

SUITCASE KIDNEY HEMODIALYSIS SYSTEM received FDA 510(k) clearance on 1978-12-07, under 510(k) number K781405.

Who is the listed applicant for SUITCASE KIDNEY HEMODIALYSIS SYSTEM?

The FDA 510(k) record lists Union Carbide Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUITCASE KIDNEY HEMODIALYSIS SYSTEM?

The FDA product code for SUITCASE KIDNEY HEMODIALYSIS SYSTEM is FKP.

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Other records listing Union Carbide Corp. as applicant

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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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