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FDA 510(k)

電子專用無菌帽

K 號：K231905 · 2023-08-14

申請人Electro-Spec, Inc.
決定日期2023-08-14
產品代碼HTY
諮詢委員會或
決定相當於

器材摘要

Electro-Spec Steri-Caps is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Spec, Inc.. It received FDA 510(k) clearance on 2023-08-14 under 510(k) number K231905. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Electro-Spec Steri-Caps?

Electro-Spec Steri-Caps is a medical device that received FDA 510(k) clearance on 2023-08-14. The listed applicant is Electro-Spec, Inc.. The 510(k) number is K231905.

When did Electro-Spec Steri-Caps receive FDA 510(k) clearance?

Electro-Spec Steri-Caps received FDA 510(k) clearance on 2023-08-14, under 510(k) number K231905.

Who is the listed applicant for Electro-Spec Steri-Caps?

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

What is the FDA product code for Electro-Spec Steri-Caps?

The FDA product code for Electro-Spec Steri-Caps is HTY.

相關臨床試驗

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相關器械（代碼：HTY）

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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