FDA 510(k)

WatchPAT400 (WP400)

K-번호: K250460 · 2025-09-05

결정일2025-09-05

제품 코드MNR

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

WatchPAT400 (WP400) is the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K250460. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the WatchPAT400 (WP400)?

WatchPAT400 (WP400) is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K250460.

When did WatchPAT400 (WP400) receive FDA 510(k) clearance?

WatchPAT400 (WP400) received FDA 510(k) clearance on 2025-09-05, under 510(k) number K250460.

Who is the listed applicant for WatchPAT400 (WP400)?

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

What is the FDA product code for WatchPAT400 (WP400)?

The FDA product code for WatchPAT400 (WP400) is MNR.

Itamar Medical , Ltd.를 신청인으로 등재한 기타 기록

K254042WatchPAT SW K223675WatchPAT ONE (WP1)K211557엔도파트엥스 K222331WatchPAT300 (WP300)K203839WatchPAT200U (WP200U)K183559WatchPAT ONE

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