FDA 510(k)

KATANA清潔器，KATANA清潔器（試用版）

K 號：K191133 · 2019-10-08

決定日期2019-10-08

產品代碼PME

諮詢委員會DE

決定相當於

器材摘要

KATANA Cleaner, KATANA Cleaner (Trial) is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-10-08 under 510(k) number K191133. The device is classified under product code PME. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KATANA Cleaner, KATANA Cleaner (Trial)?

KATANA Cleaner, KATANA Cleaner (Trial) is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K191133.

When did KATANA Cleaner, KATANA Cleaner (Trial) receive FDA 510(k) clearance?

KATANA Cleaner, KATANA Cleaner (Trial) received FDA 510(k) clearance on 2019-10-08, under 510(k) number K191133.

Who is the listed applicant for KATANA Cleaner, KATANA Cleaner (Trial)?

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

What is the FDA product code for KATANA Cleaner, KATANA Cleaner (Trial)?

The FDA product code for KATANA Cleaner, KATANA Cleaner (Trial) is PME.

其他以 Kuraray Noritake Dental, 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：PME）

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。

K163171CeraCleanBisco, Inc.

官方來源

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