FDA 510(k)

Air compression therapy system FO-3001; Air compression therapy system FO-3008

K-번호: K201982 · 2021-03-25

결정일2021-03-25

제품 코드IRP

자문 위원회의료장비 규제 텍스트 번역 PM [회사명/제품명]은 FDA(미국 식품의약국)에 등록된 의료장비로, 510(k) 신청을 통해 시장에 출시되었습니다. PMA(Premarket Approval) 신청도 진행 중입니다. 연구 참가자를 모으기 위해 NCT(National Clinical Trial) 번호 [NCT]와 PMID(Publication Medical Identifier) [PMID]를 사용하고 있습니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

결정Substantially Equivalent

기기 요약

Air compression therapy system FO-3001; Air compression therapy system FO-3008 is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Hongfeng Co., Ltd.. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K201982. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Air compression therapy system FO-3001; Air compression therapy system FO-3008?

Air compression therapy system FO-3001; Air compression therapy system FO-3008 is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Foshan Hongfeng Co., Ltd.. The 510(k) number is K201982.

When did Air compression therapy system FO-3001; Air compression therapy system FO-3008 receive FDA 510(k) clearance?

Air compression therapy system FO-3001; Air compression therapy system FO-3008 received FDA 510(k) clearance on 2021-03-25, under 510(k) number K201982.

Who is the listed applicant for Air compression therapy system FO-3001; Air compression therapy system FO-3008?

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

What is the FDA product code for Air compression therapy system FO-3001; Air compression therapy system FO-3008?

The FDA product code for Air compression therapy system FO-3001; Air compression therapy system FO-3008 is IRP.

Foshan Hongfeng Co., Ltd.를 신청인으로 등재한 기타 기록

K212169Air compression therapy system FO3002

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