FDA 510(k)

Servo-air Lite Ventilator System

K-번호: K230173 · 2023-07-06

결정일2023-07-06

제품 코드MNT

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

Servo-air Lite Ventilator System is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Critical Care AB. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K230173. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Servo-air Lite Ventilator System?

Servo-air Lite Ventilator System is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Maquet Critical Care AB. The 510(k) number is K230173.

When did Servo-air Lite Ventilator System receive FDA 510(k) clearance?

Servo-air Lite Ventilator System received FDA 510(k) clearance on 2023-07-06, under 510(k) number K230173.

Who is the listed applicant for Servo-air Lite Ventilator System?

The FDA 510(k) record lists Maquet Critical Care AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Servo-air Lite Ventilator System?

The FDA product code for Servo-air Lite Ventilator System is MNT.

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