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FDA 510(k)

核心新星 完整手術室內視鏡設備

K 號:K151282 · 2016-01-12

決定日期2016-01-12
產品代碼ODA
諮詢委員會GU
決定相當於

器材摘要

core nova Complete Operating Room Endoscopy is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K151282. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the core nova Complete Operating Room Endoscopy?

core nova Complete Operating Room Endoscopy is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K151282.

When did core nova Complete Operating Room Endoscopy receive FDA 510(k) clearance?

core nova Complete Operating Room Endoscopy received FDA 510(k) clearance on 2016-01-12, under 510(k) number K151282.

Who is the listed applicant for core nova Complete Operating Room Endoscopy?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for core nova Complete Operating Room Endoscopy?

The FDA product code for core nova Complete Operating Room Endoscopy is ODA.

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相關器械(代碼:ODA)

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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