FDA 510(k)

Infinity CentralStation Wide, Infinity M300, Infinity M300+

K-번호: K231477 · 2023-10-17

결정일2023-10-17

제품 코드MHX

자문 위원회CV

결정Substantially Equivalent

기기 요약

Infinity CentralStation Wide, Infinity M300, Infinity M300+ is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2023-10-17 under 510(k) number K231477. 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 Infinity CentralStation Wide, Infinity M300, Infinity M300+?

Infinity CentralStation Wide, Infinity M300, Infinity M300+ is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K231477.

When did Infinity CentralStation Wide, Infinity M300, Infinity M300+ receive FDA 510(k) clearance?

Infinity CentralStation Wide, Infinity M300, Infinity M300+ received FDA 510(k) clearance on 2023-10-17, under 510(k) number K231477.

Who is the listed applicant for Infinity CentralStation Wide, Infinity M300, Infinity M300+?

The FDA 510(k) record lists Draeger Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infinity CentralStation Wide, Infinity M300, Infinity M300+?

The FDA product code for Infinity CentralStation Wide, Infinity M300, Infinity M300+ is MHX.

Draeger Medical Systems, Inc.를 신청인으로 등재한 기타 기록

K260579Infinity® Acute Care System (IACS) – VG8.1 K243606Babyroo TN300 K240312Infinity CentralStation Wide K233834Infinity Gateway Suite K230278Babyroo TN300 K203579Infinity Gateway Suite

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