FDA 510(k)

Y-MIC

K 號：K161639 · 2016-12-22

決定日期2016-12-22

產品代碼ELC

諮詢委員會DE

決定相當於

器材摘要

Y-MIC is the device name listed in this FDA 510(k) record. The listed applicant is Micron Corporation. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K161639. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Y-MIC?

Y-MIC is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Micron Corporation. The 510(k) number is K161639.

When did Y-MIC receive FDA 510(k) clearance?

Y-MIC received FDA 510(k) clearance on 2016-12-22, under 510(k) number K161639.

Who is the listed applicant for Y-MIC?

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

What is the FDA product code for Y-MIC?

The FDA product code for Y-MIC is ELC.

其他以 Micron Corporation 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。

K171150AW-100

相關器械（代碼：ELC）

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。

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT機器空氣流預防主機E.M.S Electro Medical Systems S.A K251689VARIOS 170 LUX 計量系統 (VA170LUXS10)；VARIOS 170 LUX 計量系統 (VA170LUXS11)；VARIOS 170 計量系統 (VA170S11)Nakanishi, Inc.K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AG K240707超聲刮牙器（WD-JY-B002、WD-JY-W001、WD-JY-R003、WD-JY-G004、WD-JY-B003、WD-JY-C006、WD-JY-M0014、WD-JY-N0015、WD-JY-N0016、WD-JY-N0017、WD-JY-E007、WD-JY-F008、WD-JY-A005、WD-JY-H009、WD-JY-I0011、WD-JY-K0012、WD-JY-K0013、WD-JY-K0014、WD-JY-L0013、WD-JY-L0014、WD-JY-L0015、WD-JY-L0016、WD-JY-L0017）Shenzhen Micro Electric Intelligence Co., Ltd.

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。