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FDA 510(k)

莫勒醫療組織切片針及系統

K 號:K162588 · 2017-06-19

決定日期2017-06-19
產品代碼KNW
諮詢委員會GU
決定相當於

器材摘要

Möller Medical Biopsy Needles and Systems is the device name listed in this FDA 510(k) record. The listed applicant is Moller Medical GmbH. It received FDA 510(k) clearance on 2017-06-19 under 510(k) number K162588. 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 Möller Medical Biopsy Needles and Systems?

Möller Medical Biopsy Needles and Systems is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Moller Medical GmbH. The 510(k) number is K162588.

When did Möller Medical Biopsy Needles and Systems receive FDA 510(k) clearance?

Möller Medical Biopsy Needles and Systems received FDA 510(k) clearance on 2017-06-19, under 510(k) number K162588.

Who is the listed applicant for Möller Medical Biopsy Needles and Systems?

The FDA 510(k) record lists Moller Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Möller Medical Biopsy Needles and Systems?

The FDA product code for Möller Medical Biopsy Needles and Systems is KNW.

相關臨床試驗

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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。

官方來源

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