FDA 510(k)

醫療設備名稱：MED RF 4000

K 號：K210077 · 2021-12-17

決定日期2021-12-17

產品代碼ONQ

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 F Care Systems USA, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253918Veineo 系統（00MEDRF4000TCUS 05CR45iT 06Pedal1St）K252704F Care 電波系統 (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)K220725HPR45i

官方來源

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