FDA 510(k)

PainFreeze II

K 號：K232674 · 2024-02-12

決定日期2024-02-12

產品代碼MLY

決定相當於

器材摘要

PainFreeze II is the device name listed in this FDA 510(k) record. The listed applicant is Nuance Medical, LLC. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K232674. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常見問題

What is the PainFreeze II?

PainFreeze II is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Nuance Medical, LLC. The 510(k) number is K232674.

When did PainFreeze II receive FDA 510(k) clearance?

PainFreeze II received FDA 510(k) clearance on 2024-02-12, under 510(k) number K232674.

Who is the listed applicant for PainFreeze II?

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

What is the FDA product code for PainFreeze II?

The FDA product code for PainFreeze II is MLY.

其他以 Nuance Medical, LLC 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：MLY）

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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