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FDA 510(k)

FRSENIUS PD IQCARD CYCLER

K-Number: K002892 · 2001-04-05

ApplicantFresenius Medical Care North America
Decision Date2001-04-05
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRSENIUS PD IQCARD CYCLER is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K002892. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRSENIUS PD IQCARD CYCLER?

FRSENIUS PD IQCARD CYCLER is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K002892.

When did FRSENIUS PD IQCARD CYCLER receive FDA 510(k) clearance?

FRSENIUS PD IQCARD CYCLER received FDA 510(k) clearance on 2001-04-05, under 510(k) number K002892.

Who is the listed applicant for FRSENIUS PD IQCARD CYCLER?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRSENIUS PD IQCARD CYCLER?

The FDA product code for FRSENIUS PD IQCARD CYCLER is FKX.

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Related Devices (Code: FKX)

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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