FDA 510(k)

一次性半自動切片儀器

K 號：K212820 · 2022-07-06

申請人Suzhou Leapmed Healthcare Corporation

決定日期2022-07-06

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

Disposable Semi Automatic Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K212820. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Semi Automatic Biopsy Instrument?

Disposable Semi Automatic Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212820.

When did Disposable Semi Automatic Biopsy Instrument receive FDA 510(k) clearance?

Disposable Semi Automatic Biopsy Instrument received FDA 510(k) clearance on 2022-07-06, under 510(k) number K212820.

Who is the listed applicant for Disposable Semi Automatic Biopsy Instrument?

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

What is the FDA product code for Disposable Semi Automatic Biopsy Instrument?

The FDA product code for Disposable Semi Automatic Biopsy Instrument is KNW.

其他以 Suzhou Leapmed Healthcare Corporation 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。

K212819一次性組織切片針 K212822一次性同軸針吸針 K212284一次性自動核心針吸組織切片儀

相關器械（代碼：KNW）

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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