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FDA 510(k)

Empulse M90

K 號：K242327 · 2024-12-10

申請人Concourse Assistive Technology Pty, Ltd.
決定日期2024-12-10
產品代碼ITI
諮詢委員會PM
決定相當於

器材摘要

Empulse M90 is the device name listed in this FDA 510(k) record. The listed applicant is Concourse Assistive Technology Pty, Ltd.. It received FDA 510(k) clearance on 2024-12-10 under 510(k) number K242327. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Empulse M90?

Empulse M90 is a medical device that received FDA 510(k) clearance on 2024-12-10. The listed applicant is Concourse Assistive Technology Pty, Ltd.. The 510(k) number is K242327.

When did Empulse M90 receive FDA 510(k) clearance?

Empulse M90 received FDA 510(k) clearance on 2024-12-10, under 510(k) number K242327.

Who is the listed applicant for Empulse M90?

The FDA 510(k) record lists Concourse Assistive Technology Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empulse M90?

The FDA product code for Empulse M90 is ITI.

相關臨床試驗

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相關器械（代碼：ITI）

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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