FDA 510(k)

V-Mix

K 號：K193357 · 2020-10-23

決定日期2020-10-23

產品代碼KJJ

決定相當於

器材摘要

V-Mix 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 2020-10-23 under 510(k) number K193357. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

常見問題

What is the V-Mix?

V-Mix is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Inter-Med/Vista Dental Products. The 510(k) number is K193357.

When did V-Mix receive FDA 510(k) clearance?

V-Mix received FDA 510(k) clearance on 2020-10-23, under 510(k) number K193357.

Who is the listed applicant for V-Mix?

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 V-Mix?

The FDA product code for V-Mix is KJJ.

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。

K193409視野清潔器，視野清潔器加強版 K193447視界染料 K193389視界清晰 K190220Vista FS，Vista FS 液體 K170101堅毅燒烤燈

相關器械（代碼：KJJ）

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。

K250279RC-SwiftPrepBelport Company, Inc., Gingi-Pak K241354密封劑溶劑Inter-Med, Inc.K201785EPIEN 牙齒清潔器Epien Medical, Inc.K211813海神Inter-Med / Vista Dental K193409視野清潔器，視野清潔器加強版Inter-Med/Vista Dental Products K200330RC-Prime根管準備膠膏Pac-Dent, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。