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FDA 510(k)

HPR45i

K-Number: K220725 · 2023-03-20

ApplicantF Care Systems USA, LLC
Decision Date2023-03-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HPR45i 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 2023-03-20 under 510(k) number K220725. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HPR45i?

HPR45i is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is F Care Systems USA, LLC. The 510(k) number is K220725.

When did HPR45i receive FDA 510(k) clearance?

HPR45i received FDA 510(k) clearance on 2023-03-20, under 510(k) number K220725.

Who is the listed applicant for HPR45i?

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 HPR45i?

The FDA product code for HPR45i is GEI.

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)K210077MED RF 4000

Related Devices (Code: GEI)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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