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FDA 510(k)

SAM 模型 9-10000

K 號:K240100 · 2024-06-04

決定日期2024-06-04
產品代碼MNR
諮詢委員會AN
決定相當於

器材摘要

SAM Model 9-10000 is the device name listed in this FDA 510(k) record. The listed applicant is Snap Diagnostics, LLC. It received FDA 510(k) clearance on 2024-06-04 under 510(k) number K240100. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SAM Model 9-10000?

SAM Model 9-10000 is a medical device that received FDA 510(k) clearance on 2024-06-04. The listed applicant is Snap Diagnostics, LLC. The 510(k) number is K240100.

When did SAM Model 9-10000 receive FDA 510(k) clearance?

SAM Model 9-10000 received FDA 510(k) clearance on 2024-06-04, under 510(k) number K240100.

Who is the listed applicant for SAM Model 9-10000?

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

What is the FDA product code for SAM Model 9-10000?

The FDA product code for SAM Model 9-10000 is MNR.

相關臨床試驗

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相關器械(代碼:MNR)

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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