FDA 510(k)

視界清晰

K 號：K193389 · 2020-03-04

決定日期2020-03-04

產品代碼MVL

決定相當於

器材摘要

Vista Clear is the device name listed in this FDA 510(k) record. The listed applicant is Inter-Med/Vista Dental Products. It received FDA 510(k) clearance on 2020-03-04 under 510(k) number K193389. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

常見問題

What is the Vista Clear?

Vista Clear is a medical device that received FDA 510(k) clearance on 2020-03-04. The listed applicant is Inter-Med/Vista Dental Products. The 510(k) number is K193389.

When did Vista Clear receive FDA 510(k) clearance?

Vista Clear received FDA 510(k) clearance on 2020-03-04, under 510(k) number K193389.

Who is the listed applicant for Vista Clear?

The FDA 510(k) record lists Inter-Med/Vista Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vista Clear?

The FDA product code for Vista Clear is MVL.

其他以 Inter-Med/Vista Dental Products 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。

K193357V-Mix K193409視野清潔器，視野清潔器加強版 K193447視界染料 K190220Vista FS，Vista FS 液體 K170101堅毅燒烤燈

相關器械（代碼：MVL）

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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