FDA 510(k)

迷你脊形過濾器及PROBEAT-V輔助功能

K 號：K181676 · 2018-08-15

申請人Hitachi Ltd. Healthcare Hitachi Works

決定日期2018-08-15

產品代碼LHN

諮詢委員會RA

決定相當於

器材摘要

Mini Ridge Filter and auxiliary functions for PROBEAT-V is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Ltd. Healthcare Hitachi Works. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K181676. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mini Ridge Filter and auxiliary functions for PROBEAT-V?

Mini Ridge Filter and auxiliary functions for PROBEAT-V is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Hitachi Ltd. Healthcare Hitachi Works. The 510(k) number is K181676.

When did Mini Ridge Filter and auxiliary functions for PROBEAT-V receive FDA 510(k) clearance?

Mini Ridge Filter and auxiliary functions for PROBEAT-V received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181676.

Who is the listed applicant for Mini Ridge Filter and auxiliary functions for PROBEAT-V?

The FDA 510(k) record lists Hitachi Ltd. Healthcare Hitachi Works as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mini Ridge Filter and auxiliary functions for PROBEAT-V?

The FDA product code for Mini Ridge Filter and auxiliary functions for PROBEAT-V is LHN.

相關器械（代碼：LHN）

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。

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LHN）

官方來源