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FDA 510(k)

Simpleware 扫描IP醫療設備

K 號:K203195 · 2021-04-01

決定日期2021-04-01
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

Simpleware ScanIP Medical is the device name listed in this FDA 510(k) record. The listed applicant is Synopsys (Northern Europe) , Ltd.. It received FDA 510(k) clearance on 2021-04-01 under 510(k) number K203195. 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 Simpleware ScanIP Medical?

Simpleware ScanIP Medical is a medical device that received FDA 510(k) clearance on 2021-04-01. The listed applicant is Synopsys (Northern Europe) , Ltd.. The 510(k) number is K203195.

When did Simpleware ScanIP Medical receive FDA 510(k) clearance?

Simpleware ScanIP Medical received FDA 510(k) clearance on 2021-04-01, under 510(k) number K203195.

Who is the listed applicant for Simpleware ScanIP Medical?

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

What is the FDA product code for Simpleware ScanIP Medical?

The FDA product code for Simpleware ScanIP Medical is LLZ.

相關臨床試驗

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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。

官方來源

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