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FDA 510(k)

MEGA-IOM系統搭配Neuro-IOM.NET軟體（32/B - 32/S - 16/S）

K 號：K234080 · 2024-03-25

申請人Soterix Medical, Inc.
決定日期2024-03-25
產品代碼GWF
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) is the device name listed in this FDA 510(k) record. The listed applicant is Soterix Medical, Inc.. It received FDA 510(k) clearance on 2024-03-25 under 510(k) number K234080. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)?

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) is a medical device that received FDA 510(k) clearance on 2024-03-25. The listed applicant is Soterix Medical, Inc.. The 510(k) number is K234080.

When did MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) receive FDA 510(k) clearance?

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) received FDA 510(k) clearance on 2024-03-25, under 510(k) number K234080.

Who is the listed applicant for MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)?

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

What is the FDA product code for MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)?

The FDA product code for MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) is GWF.

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相關器械（代碼：GWF）

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