指尖血氧計 A310
K 號：K153021 · 2016-11-22
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器材摘要
Fingertip Pulse Oximeter A310 is the device name listed in this FDA 510(k) record. The listed applicant is Amemo, Inc.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K153021. 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 Fingertip Pulse Oximeter A310?
Fingertip Pulse Oximeter A310 is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Amemo, Inc.. The 510(k) number is K153021.
When did Fingertip Pulse Oximeter A310 receive FDA 510(k) clearance?
Fingertip Pulse Oximeter A310 received FDA 510(k) clearance on 2016-11-22, under 510(k) number K153021.
Who is the listed applicant for Fingertip Pulse Oximeter A310?
The FDA 510(k) record lists Amemo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fingertip Pulse Oximeter A310?
The FDA product code for Fingertip Pulse Oximeter A310 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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