FDA 510(k)

패스포트 시리즈 환자 모니터 (패스포트 8, 패스포트 12 포함)

K-번호: K153448 · 2016-03-03

신청자Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

결정일2016-03-03

제품 코드MHX

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

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기기 요약

Passport Series Patient Monitors (Including Passport 8, Passport 12) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K153448. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Passport Series Patient Monitors (Including Passport 8, Passport 12)?

Passport Series Patient Monitors (Including Passport 8, Passport 12) is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K153448.

When did Passport Series Patient Monitors (Including Passport 8, Passport 12) receive FDA 510(k) clearance?

Passport Series Patient Monitors (Including Passport 8, Passport 12) received FDA 510(k) clearance on 2016-03-03, under 510(k) number K153448.

Who is the listed applicant for Passport Series Patient Monitors (Including Passport 8, Passport 12)?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Passport Series Patient Monitors (Including Passport 8, Passport 12)?

The FDA product code for Passport Series Patient Monitors (Including Passport 8, Passport 12) is MHX.

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