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K 號：K153705 · 2016-09-02
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器材摘要
PROcedure Rehearsal Studio is the device name listed in this FDA 510(k) record. The listed applicant is 3Dsystems, Simbionix Products. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K153705. 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 PROcedure Rehearsal Studio?
PROcedure Rehearsal Studio is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is 3Dsystems, Simbionix Products. The 510(k) number is K153705.
When did PROcedure Rehearsal Studio receive FDA 510(k) clearance?
PROcedure Rehearsal Studio received FDA 510(k) clearance on 2016-09-02, under 510(k) number K153705.
Who is the listed applicant for PROcedure Rehearsal Studio?
The FDA 510(k) record lists 3Dsystems, Simbionix Products as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PROcedure Rehearsal Studio?
The FDA product code for PROcedure Rehearsal Studio is LLZ.
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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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