FDA 510(k)

nView s1 配備導航選項

K 號：K221344 · 2022-12-28

決定日期2022-12-28

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

nView s1 with nav option is the device name listed in this FDA 510(k) record. The listed applicant is Nview Medical. It received FDA 510(k) clearance on 2022-12-28 under 510(k) number K221344. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the nView s1 with nav option?

nView s1 with nav option is a medical device that received FDA 510(k) clearance on 2022-12-28. The listed applicant is Nview Medical. The 510(k) number is K221344.

When did nView s1 with nav option receive FDA 510(k) clearance?

nView s1 with nav option received FDA 510(k) clearance on 2022-12-28, under 510(k) number K221344.

Who is the listed applicant for nView s1 with nav option?

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

What is the FDA product code for nView s1 with nav option?

The FDA product code for nView s1 with nav option is OWB.

其他以 Nview Medical 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。

K211064nView s1 配備導航選項

相關器械（代碼：OWB）

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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