FDA 510(k)

core nova Complete Operating Room Endoscopy

K番号: K151282 · 2016-01-12

申請者Richard Wolf Medical Instruments Corp.

決定日2016-01-12

製品コードODA

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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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core nova Complete Operating Room Endoscopy

医療機器の概要

よくある質問

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