FDA 510(k)

Theradome LH40

K 號：K180460 · 2018-05-18

決定日期2018-05-18

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Theradome LH40 is the device name listed in this FDA 510(k) record. The listed applicant is Theradome, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180460. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Theradome LH40?

Theradome LH40 is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Theradome, Inc.. The 510(k) number is K180460.

When did Theradome LH40 receive FDA 510(k) clearance?

Theradome LH40 received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180460.

Who is the listed applicant for Theradome LH40?

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

What is the FDA product code for Theradome LH40?

The FDA product code for Theradome LH40 is OAP.

其他以 Theradome, Inc. 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。

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相關器械（代碼：OAP）

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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