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FDA 510(k)

PhySoftAMS®

K 號:K232283 · 2023-12-14

決定日期2023-12-14
產品代碼MQS
諮詢委員會GU
決定相當於

器材摘要

PhySoftAMS® is the device name listed in this FDA 510(k) record. The listed applicant is Physician Software Systems, LLC. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K232283. The device is classified under product code MQS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PhySoftAMS®?

PhySoftAMS® is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Physician Software Systems, LLC. The 510(k) number is K232283.

When did PhySoftAMS® receive FDA 510(k) clearance?

PhySoftAMS® received FDA 510(k) clearance on 2023-12-14, under 510(k) number K232283.

Who is the listed applicant for PhySoftAMS®?

The FDA 510(k) record lists Physician Software Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PhySoftAMS®?

The FDA product code for PhySoftAMS® is MQS.

相關臨床試驗

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相關器械(代碼:MQS)

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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