FDA 510(k)

ABLATE-IQ

K 號：K232227 · 2024-04-04

決定日期2024-04-04

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

ABLATE-IQ is the device name listed in this FDA 510(k) record. The listed applicant is Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K232227. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ABLATE-IQ?

ABLATE-IQ is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Neuwave Medical, Inc.. The 510(k) number is K232227.

When did ABLATE-IQ receive FDA 510(k) clearance?

ABLATE-IQ received FDA 510(k) clearance on 2024-04-04, under 510(k) number K232227.

Who is the listed applicant for ABLATE-IQ?

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

What is the FDA product code for ABLATE-IQ?

The FDA product code for ABLATE-IQ is JAK.

其他以 Neuwave Medical, Inc. 為申請人之記錄

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相關器械（代碼：JAK）

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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