FDA 510(k)

VMAT PRO

K 號：K243488 · 2025-02-06

決定日期2025-02-06

產品代碼ISA

諮詢委員會PM

決定相當於

器材摘要

VMAT PRO is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K243488. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VMAT PRO?

VMAT PRO is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Termosalud. The 510(k) number is K243488.

When did VMAT PRO receive FDA 510(k) clearance?

VMAT PRO received FDA 510(k) clearance on 2025-02-06, under 510(k) number K243488.

Who is the listed applicant for VMAT PRO?

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

What is the FDA product code for VMAT PRO?

The FDA product code for VMAT PRO is ISA.

其他以 Termosalud 為申請人之記錄

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相關器械（代碼：ISA）

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官方來源

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