FDA 510(k)

Neuronaute 配 IceCap 2 及 IceCap 2 小型

K 號：K223644 · 2023-01-12

決定日期2023-01-12

產品代碼GWQ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Neuronaute with IceCap 2 & IceCap 2 Small is the device name listed in this FDA 510(k) record. The listed applicant is Bioserenity. It received FDA 510(k) clearance on 2023-01-12 under 510(k) number K223644. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neuronaute with IceCap 2 & IceCap 2 Small?

Neuronaute with IceCap 2 & IceCap 2 Small is a medical device that received FDA 510(k) clearance on 2023-01-12. The listed applicant is Bioserenity. The 510(k) number is K223644.

When did Neuronaute with IceCap 2 & IceCap 2 Small receive FDA 510(k) clearance?

Neuronaute with IceCap 2 & IceCap 2 Small received FDA 510(k) clearance on 2023-01-12, under 510(k) number K223644.

Who is the listed applicant for Neuronaute with IceCap 2 & IceCap 2 Small?

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

What is the FDA product code for Neuronaute with IceCap 2 & IceCap 2 Small?

The FDA product code for Neuronaute with IceCap 2 & IceCap 2 Small is GWQ.

其他以 Bioserenity 為申請人之記錄

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K170138神經航行者

相關器械（代碼：GWQ）

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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