FDA 510(k)

Corplex P / Theracor P / Allacor P

K 號：K231325 · 2024-02-02

決定日期2024-02-02

產品代碼KGN

決定相當於

器材摘要

Corplex P / Theracor P / Allacor P is the device name listed in this FDA 510(k) record. The listed applicant is Stimlabs, LLC. It received FDA 510(k) clearance on 2024-02-02 under 510(k) number K231325. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the Corplex P / Theracor P / Allacor P?

Corplex P / Theracor P / Allacor P is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Stimlabs, LLC. The 510(k) number is K231325.

When did Corplex P / Theracor P / Allacor P receive FDA 510(k) clearance?

Corplex P / Theracor P / Allacor P received FDA 510(k) clearance on 2024-02-02, under 510(k) number K231325.

Who is the listed applicant for Corplex P / Theracor P / Allacor P?

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

What is the FDA product code for Corplex P / Theracor P / Allacor P?

The FDA product code for Corplex P / Theracor P / Allacor P is KGN.

其他以 Stimlabs, LLC 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。

K253339Theracor K242828Corplex P/ Theracor P/ Allacor P

相關器械（代碼：KGN）

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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