FDA 510(k)

Whitsundays Mask System

K-번호: K223747 · 2023-07-06

신청자Resmed Pty Ltd (Registration Number: 3004604967)

결정일2023-07-06

제품 코드BZD

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

Whitsundays Mask System is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K223747. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Whitsundays Mask System?

Whitsundays Mask System is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). The 510(k) number is K223747.

When did Whitsundays Mask System receive FDA 510(k) clearance?

Whitsundays Mask System received FDA 510(k) clearance on 2023-07-06, under 510(k) number K223747.

Who is the listed applicant for Whitsundays Mask System?

The FDA 510(k) record lists Resmed Pty Ltd (Registration Number: 3004604967) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Whitsundays Mask System?

The FDA product code for Whitsundays Mask System is BZD.

Resmed Pty Ltd (Registration Number: 3004604967)를 신청인으로 등재한 기타 기록

K234134AirFit F30i 마스크 시스템; AirFit F30i NM 마스크 시스템; Arcadia 마스크 시스템 K230476Oran Park Mask

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