FDA 510(k)

IS3

K 號：K180527 · 2018-05-16

決定日期2018-05-16

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

IS3 is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2018-05-16 under 510(k) number K180527. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IS3?

IS3 is a medical device that received FDA 510(k) clearance on 2018-05-16. The listed applicant is Hiossen, Inc.. The 510(k) number is K180527.

When did IS3 receive FDA 510(k) clearance?

IS3 received FDA 510(k) clearance on 2018-05-16, under 510(k) number K180527.

Who is the listed applicant for IS3?

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

What is the FDA product code for IS3?

The FDA product code for IS3 is EKX.

其他以 Hiossen, 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。

K253372ET治療基座；ET掃描治療基座；EK掃描治療基座 K251427EK多角度30牙根座 K241003HIOSSEN 預製基座（ET 預製基座 & EK 預製基座）K240232EK D3.3 及超廣角植入體 K233389EK數位牙根支台 K222636ET牙根擴張系統

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相關器械（代碼：EKX）

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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