FDA 510(k)

MC1 Plus

K 號：K161502 · 2016-08-16

決定日期2016-08-16

產品代碼IMI

諮詢委員會PM

決定相當於

器材摘要

MC1 Plus is the device name listed in this FDA 510(k) record. The listed applicant is General Project S.R.L.. It received FDA 510(k) clearance on 2016-08-16 under 510(k) number K161502. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MC1 Plus?

MC1 Plus is a medical device that received FDA 510(k) clearance on 2016-08-16. The listed applicant is General Project S.R.L.. The 510(k) number is K161502.

When did MC1 Plus receive FDA 510(k) clearance?

MC1 Plus received FDA 510(k) clearance on 2016-08-16, under 510(k) number K161502.

Who is the listed applicant for MC1 Plus?

The FDA 510(k) record lists General Project S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MC1 Plus?

The FDA product code for MC1 Plus is IMI.

相關器械（代碼：IMI）

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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