FDA 510(k)

Mariana Minerva; Mariana Nimbus

K-번호: K251661 · 2026-02-23

결정일2026-02-23

제품 코드MNS

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

Mariana Minerva; Mariana Nimbus is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Pty , Ltd.. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K251661. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Mariana Minerva; Mariana Nimbus?

Mariana Minerva; Mariana Nimbus is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Resmed Pty , Ltd.. The 510(k) number is K251661.

When did Mariana Minerva; Mariana Nimbus receive FDA 510(k) clearance?

Mariana Minerva; Mariana Nimbus received FDA 510(k) clearance on 2026-02-23, under 510(k) number K251661.

Who is the listed applicant for Mariana Minerva; Mariana Nimbus?

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

What is the FDA product code for Mariana Minerva; Mariana Nimbus?

The FDA product code for Mariana Minerva; Mariana Nimbus is MNS. This falls under the Neurology category.

Resmed Pty , Ltd.를 신청인으로 등재한 기타 기록

K242547AirFit F20 마스크 시스템; AirFit F20 NM 마스크 시스템 K203126S10 Kirra

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