FDA 510(k)

一次性內外科探針 (DIOP8)

K 號：K201425 · 2021-02-19

決定日期2021-02-19

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

Disposable Intraoperative Probe (DIOP8) is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare Limited. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K201425. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Intraoperative Probe (DIOP8)?

Disposable Intraoperative Probe (DIOP8) is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Huntleigh Healthcare Limited. The 510(k) number is K201425.

When did Disposable Intraoperative Probe (DIOP8) receive FDA 510(k) clearance?

Disposable Intraoperative Probe (DIOP8) received FDA 510(k) clearance on 2021-02-19, under 510(k) number K201425.

Who is the listed applicant for Disposable Intraoperative Probe (DIOP8)?

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

What is the FDA product code for Disposable Intraoperative Probe (DIOP8)?

The FDA product code for Disposable Intraoperative Probe (DIOP8) is ITX.

其他以 Huntleigh Healthcare Limited 為申請人之記錄

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相關器械（代碼：ITX）

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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