FDA 510(k)

天然橡膠乳膠超聲波傳感器探頭覆蓋物

K 號：K213087 · 2022-06-07

決定日期2022-06-07

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

Natural Rubber Latex Ultrasound Transducer Probe Covers is the device name listed in this FDA 510(k) record. The listed applicant is Global Protection Corp.. It received FDA 510(k) clearance on 2022-06-07 under 510(k) number K213087. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Natural Rubber Latex Ultrasound Transducer Probe Covers?

Natural Rubber Latex Ultrasound Transducer Probe Covers is a medical device that received FDA 510(k) clearance on 2022-06-07. The listed applicant is Global Protection Corp.. The 510(k) number is K213087.

When did Natural Rubber Latex Ultrasound Transducer Probe Covers receive FDA 510(k) clearance?

Natural Rubber Latex Ultrasound Transducer Probe Covers received FDA 510(k) clearance on 2022-06-07, under 510(k) number K213087.

Who is the listed applicant for Natural Rubber Latex Ultrasound Transducer Probe Covers?

The FDA 510(k) record lists Global Protection Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Natural Rubber Latex Ultrasound Transducer Probe Covers?

The FDA product code for Natural Rubber Latex Ultrasound Transducer Probe Covers is ITX.

其他以 Global Protection Corp. 為申請人之記錄

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相關器械（代碼：ITX）

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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