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FDA 510(k)

EVRF SYSTEM

K-Number: K130283 · 2013-03-07

ApplicantF Care Systems NV
Decision Date2013-03-07
Product CodeONQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EVRF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is F Care Systems NV. It received FDA 510(k) clearance on 2013-03-07 under 510(k) number K130283. The device is classified under product code ONQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVRF SYSTEM?

EVRF SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-07. The listed applicant is F Care Systems NV. The 510(k) number is K130283.

When did EVRF SYSTEM receive FDA 510(k) clearance?

EVRF SYSTEM received FDA 510(k) clearance on 2013-03-07, under 510(k) number K130283.

Who is the listed applicant for EVRF SYSTEM?

The FDA 510(k) record lists F Care Systems NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVRF SYSTEM?

The FDA product code for EVRF SYSTEM is ONQ.

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Related Devices (Code: ONQ)

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.

K210077MED RF 4000F Care Systems USA, LLCK112334VEIN-GOGH INSTRUMENTRefine USA, LLCK083352VEINWAVE, TC3000Newlands Clinical Trials, Ltd.

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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