FDA 510(k)

Delta III 鹽結石擊碎機

K 號：K201074 · 2020-09-03

決定日期2020-09-03

產品代碼LNS

諮詢委員會GU

決定相當於

器材摘要

Delta III Lithotripter is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K201074. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Delta III Lithotripter?

Delta III Lithotripter is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K201074.

When did Delta III Lithotripter receive FDA 510(k) clearance?

Delta III Lithotripter received FDA 510(k) clearance on 2020-09-03, under 510(k) number K201074.

Who is the listed applicant for Delta III Lithotripter?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Delta III Lithotripter?

The FDA product code for Delta III Lithotripter is LNS.

其他以 Dornier Medtech America, Inc. 為申請人之記錄

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相關器械（代碼：LNS）

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。

K261086破浪Sonomotion, Inc.K252913破浪Sonomotion, Inc.K242922體外震波碎石機 (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.K221903Delta III ProDornier Medtech America, Inc.K213772LM-9300 Plus 鑫石碎機Lite-Med, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy America

官方來源

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