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FDA 510(k)

SOTA雲端智慧感測器(1.5)

K 號:K251793 · 2026-03-03

決定日期2026-03-03
產品代碼MUH
諮詢委員會DE
決定相當於

器材摘要

SOTA Cloud Smart Sensor (1.5) is the device name listed in this FDA 510(k) record. The listed applicant is Sota Cloud Corp.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K251793. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SOTA Cloud Smart Sensor (1.5)?

SOTA Cloud Smart Sensor (1.5) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Sota Cloud Corp.. The 510(k) number is K251793.

When did SOTA Cloud Smart Sensor (1.5) receive FDA 510(k) clearance?

SOTA Cloud Smart Sensor (1.5) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K251793.

Who is the listed applicant for SOTA Cloud Smart Sensor (1.5)?

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

What is the FDA product code for SOTA Cloud Smart Sensor (1.5)?

The FDA product code for SOTA Cloud Smart Sensor (1.5) is MUH.

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相關器械(代碼:MUH)

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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