FDA 510(k)

森尼奧檢測

K 號：K240406 · 2024-04-26

申請人Sonio

決定日期2024-04-26

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Sonio Detect is the device name listed in this FDA 510(k) record. The listed applicant is Sonio. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K240406. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sonio Detect?

Sonio Detect is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Sonio. The 510(k) number is K240406.

When did Sonio Detect receive FDA 510(k) clearance?

Sonio Detect received FDA 510(k) clearance on 2024-04-26, under 510(k) number K240406.

Who is the listed applicant for Sonio Detect?

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

What is the FDA product code for Sonio Detect?

The FDA product code for Sonio Detect is IYN.

其他以 Sonio 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。

K261519Sonio懷疑 K252433Sonio Detect (v3)K243614Sonio懷疑 K230365森尼奧檢測

相關器械（代碼：IYN）

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。

官方來源

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