FDA 510(k)

MEGA-IOM 시스템과 Neuro-IOM.NET 소프트웨어 (32/B - 32/S - 16/S)

K-번호: K234080 · 2024-03-25

결정일2024-03-25

제품 코드GWF

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Soterix Medical, Inc.를 신청인으로 등재한 기타 기록

K251653스프라이 TMS 테라피 시스템 (0550)K233751미일브이 (YPS-301BD)K192823MEGA-TMS K191422뇌내비게이터 K170291이온도시디

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