FDA 510(k)

Xenoview VDP

K 號：K223071 · 2022-12-23

決定日期2022-12-23

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Xenoview VDP is the device name listed in this FDA 510(k) record. The listed applicant is Polarean, Inc.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K223071. 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 Xenoview VDP?

Xenoview VDP is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Polarean, Inc.. The 510(k) number is K223071.

When did Xenoview VDP receive FDA 510(k) clearance?

Xenoview VDP received FDA 510(k) clearance on 2022-12-23, under 510(k) number K223071.

Who is the listed applicant for Xenoview VDP?

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

What is the FDA product code for Xenoview VDP?

The FDA product code for Xenoview VDP is LLZ.

其他以 Polarean, 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。

K243316XENOVIEW 3.0T 胸部線圈 K231647XENOVIEW 3.0T 胸部線圈 K212239XENOVIEW 3.0T 胸部線圈

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。

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官方來源

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