FDA 510(k)

Infinity Acute Care System (IACS) Monitoring System

K-번호: K203088 · 2022-02-01

결정일2022-02-01

제품 코드MHX

자문 위원회CV

결정Substantially Equivalent

기기 요약

Infinity Acute Care System (IACS) Monitoring System 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 2022-02-01 under 510(k) number K203088. 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 Acute Care System (IACS) Monitoring System?

Infinity Acute Care System (IACS) Monitoring System is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K203088.

When did Infinity Acute Care System (IACS) Monitoring System receive FDA 510(k) clearance?

Infinity Acute Care System (IACS) Monitoring System received FDA 510(k) clearance on 2022-02-01, under 510(k) number K203088.

Who is the listed applicant for Infinity Acute Care System (IACS) Monitoring System?

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 Acute Care System (IACS) Monitoring System?

The FDA product code for Infinity Acute Care System (IACS) Monitoring System 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 K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+K230278Babyroo TN300

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