FDA 510(k)

BAROnova 擷取套件，BAROnova 開放管，BAROnova 経驗帽

K 號：K172575 · 2018-01-18

決定日期2018-01-18

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is the device name listed in this FDA 510(k) record. The listed applicant is Baronova, Inc.. It received FDA 510(k) clearance on 2018-01-18 under 510(k) number K172575. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap?

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is a medical device that received FDA 510(k) clearance on 2018-01-18. The listed applicant is Baronova, Inc.. The 510(k) number is K172575.

When did BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap receive FDA 510(k) clearance?

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap received FDA 510(k) clearance on 2018-01-18, under 510(k) number K172575.

Who is the listed applicant for BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap?

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

What is the FDA product code for BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap?

The FDA product code for BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap is FED.

其他以 Baronova, Inc. 為申請人之記錄

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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相關器械（代碼：FED）

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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