FDA 510(k)

變頻淋巴12 pro

K 號：K193476 · 2020-08-19

決定日期2020-08-19

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

VariLymph 12 pro is the device name listed in this FDA 510(k) record. The listed applicant is Slk Medical GmbH. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K193476. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VariLymph 12 pro?

VariLymph 12 pro is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Slk Medical GmbH. The 510(k) number is K193476.

When did VariLymph 12 pro receive FDA 510(k) clearance?

VariLymph 12 pro received FDA 510(k) clearance on 2020-08-19, under 510(k) number K193476.

Who is the listed applicant for VariLymph 12 pro?

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

What is the FDA product code for VariLymph 12 pro?

The FDA product code for VariLymph 12 pro is JOW.

其他以 Slk Medical GmbH 為申請人之記錄

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K210913V12 PRO

相關器械（代碼：JOW）

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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