FDA 510(k)

SimpliMed 90Y

K 號：K182016 · 2018-12-06

決定日期2018-12-06

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Simplicit90Y is the device name listed in this FDA 510(k) record. The listed applicant is Mirada Medical, Ltd.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K182016. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Simplicit90Y?

Simplicit90Y is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Mirada Medical, Ltd.. The 510(k) number is K182016.

When did Simplicit90Y receive FDA 510(k) clearance?

Simplicit90Y received FDA 510(k) clearance on 2018-12-06, under 510(k) number K182016.

Who is the listed applicant for Simplicit90Y?

The FDA 510(k) record lists Mirada Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplicit90Y?

The FDA product code for Simplicit90Y is LLZ.

其他以 Mirada Medical, Ltd. 為申請人之記錄

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相關器械（代碼：LLZ）

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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