FDA 510(k)

V80 Anesthetic Vaporizer (V80)

K-번호: K240375 · 2024-10-31

신청자Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

결정일2024-10-31

제품 코드CAD

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

V80 Anesthetic Vaporizer (V80) 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 2024-10-31 under 510(k) number K240375. The device is classified under product code CAD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the V80 Anesthetic Vaporizer (V80)?

V80 Anesthetic Vaporizer (V80) is a medical device that received FDA 510(k) clearance on 2024-10-31. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K240375.

When did V80 Anesthetic Vaporizer (V80) receive FDA 510(k) clearance?

V80 Anesthetic Vaporizer (V80) received FDA 510(k) clearance on 2024-10-31, under 510(k) number K240375.

Who is the listed applicant for V80 Anesthetic Vaporizer (V80)?

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 V80 Anesthetic Vaporizer (V80)?

The FDA product code for V80 Anesthetic Vaporizer (V80) is CAD.

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