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FDA 510(k)

MED RF 4000

K-Number: K210077 · 2021-12-17

ApplicantF Care Systems USA, LLC
Decision Date2021-12-17
Product CodeONQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MED RF 4000 is the device name listed in this FDA 510(k) record. The listed applicant is F Care Systems USA, LLC. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K210077. 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 MED RF 4000?

MED RF 4000 is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is F Care Systems USA, LLC. The 510(k) number is K210077.

When did MED RF 4000 receive FDA 510(k) clearance?

MED RF 4000 received FDA 510(k) clearance on 2021-12-17, under 510(k) number K210077.

Who is the listed applicant for MED RF 4000?

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

What is the FDA product code for MED RF 4000?

The FDA product code for MED RF 4000 is ONQ.

Other records listing F Care Systems USA, LLC as applicant

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.

K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)K220725HPR45i

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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