FDA 510(k)

AccurSound 전자 스테로스코프 (AS101)

K-번호: K242971 · 2024-11-25

결정일2024-11-25

제품 코드DQD

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

결정Substantially Equivalent

기기 요약

AccurSound Electronic Stethoscope (AS101) is the device name listed in this FDA 510(k) record. The listed applicant is Heroic Faith International , Ltd.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K242971. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AccurSound Electronic Stethoscope (AS101)?

AccurSound Electronic Stethoscope (AS101) is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Heroic Faith International , Ltd.. The 510(k) number is K242971.

When did AccurSound Electronic Stethoscope (AS101) receive FDA 510(k) clearance?

AccurSound Electronic Stethoscope (AS101) received FDA 510(k) clearance on 2024-11-25, under 510(k) number K242971.

Who is the listed applicant for AccurSound Electronic Stethoscope (AS101)?

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

What is the FDA product code for AccurSound Electronic Stethoscope (AS101)?

The FDA product code for AccurSound Electronic Stethoscope (AS101) is DQD.

Heroic Faith International , Ltd.를 신청인으로 등재한 기타 기록

K242798Airmod K221805AccurSound Electronic Stethoscope AS-101

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