FDA 510(k)

維斯比醫療呼吸健康檢測

K 號：K242526 · 2025-02-19

決定日期2025-02-19

產品代碼QOF

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Visby Medical Respiratory Health Test is the device name listed in this FDA 510(k) record. The listed applicant is Visby Medical, Inc.. It received FDA 510(k) clearance on 2025-02-19 under 510(k) number K242526. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Visby Medical Respiratory Health Test?

Visby Medical Respiratory Health Test is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Visby Medical, Inc.. The 510(k) number is K242526.

When did Visby Medical Respiratory Health Test receive FDA 510(k) clearance?

Visby Medical Respiratory Health Test received FDA 510(k) clearance on 2025-02-19, under 510(k) number K242526.

Who is the listed applicant for Visby Medical Respiratory Health Test?

The FDA 510(k) record lists Visby Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visby Medical Respiratory Health Test?

The FDA product code for Visby Medical Respiratory Health Test is QOF.

其他以 Visby Medical, Inc. 為申請人之記錄

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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相關器械（代碼：QOF）

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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