波索智慧手錶
K 號：K220351 · 2022-11-18
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器材摘要
Polso Watch is the device name listed in this FDA 510(k) record. The listed applicant is Chronisense Medical, Ltd.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K220351. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Polso Watch?
Polso Watch is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Chronisense Medical, Ltd.. The 510(k) number is K220351.
When did Polso Watch receive FDA 510(k) clearance?
Polso Watch received FDA 510(k) clearance on 2022-11-18, under 510(k) number K220351.
Who is the listed applicant for Polso Watch?
The FDA 510(k) record lists Chronisense Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Polso Watch?
The FDA product code for Polso Watch is DQA.
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相關器械（代碼：DQA）
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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