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FDA 510(k)

G-Tech無線貼片系統(WPS)

K 號:K212954 · 2022-01-10

決定日期2022-01-10
產品代碼MYE
諮詢委員會GU
決定相當於

器材摘要

G-Tech Wireless Patch System (WPS) is the device name listed in this FDA 510(k) record. The listed applicant is G-Tech Medical. It received FDA 510(k) clearance on 2022-01-10 under 510(k) number K212954. The device is classified under product code MYE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the G-Tech Wireless Patch System (WPS)?

G-Tech Wireless Patch System (WPS) is a medical device that received FDA 510(k) clearance on 2022-01-10. The listed applicant is G-Tech Medical. The 510(k) number is K212954.

When did G-Tech Wireless Patch System (WPS) receive FDA 510(k) clearance?

G-Tech Wireless Patch System (WPS) received FDA 510(k) clearance on 2022-01-10, under 510(k) number K212954.

Who is the listed applicant for G-Tech Wireless Patch System (WPS)?

The FDA 510(k) record lists G-Tech Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G-Tech Wireless Patch System (WPS)?

The FDA product code for G-Tech Wireless Patch System (WPS) is MYE.

相關臨床試驗

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。

相關器械(代碼:MYE)

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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