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FDA 510(k)

FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM

K-Number: K921456 · 1994-04-20

ApplicantFresenius USA, Inc.
Decision Date1994-04-20
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1994-04-20 under 510(k) number K921456. 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 FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM?

FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1994-04-20. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K921456.

When did FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM receive FDA 510(k) clearance?

FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM received FDA 510(k) clearance on 1994-04-20, under 510(k) number K921456.

Who is the listed applicant for FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM?

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

What is the FDA product code for FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM?

The FDA product code for FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM is FKP.

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Other records listing Fresenius USA, Inc. as applicant

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Related Devices (Code: FKP)

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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