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FDA 510(k)

PROBEAT-CR

K 號：K260174 · 2026-06-11

申請人Hitachi High-Tech Corp.
決定日期2026-06-11
產品代碼LHN
諮詢委員會RA
決定相當於

器材摘要

PROBEAT-CR is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi High-Tech Corp.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K260174. 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 PROBEAT-CR?

PROBEAT-CR is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Hitachi High-Tech Corp.. The 510(k) number is K260174.

When did PROBEAT-CR receive FDA 510(k) clearance?

PROBEAT-CR received FDA 510(k) clearance on 2026-06-11, under 510(k) number K260174.

Who is the listed applicant for PROBEAT-CR?

The FDA 510(k) record lists Hitachi High-Tech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROBEAT-CR?

The FDA product code for PROBEAT-CR is LHN.

相關臨床試驗

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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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