FDA 510(k)

AirFit F30i 마스크 시스템; AirFit F30i NM 마스크 시스템; Arcadia 마스크 시스템

K-번호: K234134 · 2024-09-24

신청자Resmed Pty Ltd (Registration Number: 3004604967)

결정일2024-09-24

제품 코드BZD

자문 위원회AN

결정Substantially Equivalent

기기 요약

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia 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 2024-09-24 under 510(k) number K234134. 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 AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System?

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System is a medical device that received FDA 510(k) clearance on 2024-09-24. The listed applicant is Resmed Pty Ltd (Registration Number: 3004604967). The 510(k) number is K234134.

When did AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System receive FDA 510(k) clearance?

AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System received FDA 510(k) clearance on 2024-09-24, under 510(k) number K234134.

Who is the listed applicant for AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia 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 AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System?

The FDA product code for AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System is BZD.

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

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