FDA 510(k)

ulrichINJECT CT Motion (XD 8000)

K-번호: K251295 · 2025-11-07

결정일2025-11-07

제품 코드IZQ

자문 위원회CV

결정Substantially Equivalent

기기 요약

ulrichINJECT CT Motion (XD 8000) is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K251295. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ulrichINJECT CT Motion (XD 8000)?

ulrichINJECT CT Motion (XD 8000) is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K251295.

When did ulrichINJECT CT Motion (XD 8000) receive FDA 510(k) clearance?

ulrichINJECT CT Motion (XD 8000) received FDA 510(k) clearance on 2025-11-07, under 510(k) number K251295.

Who is the listed applicant for ulrichINJECT CT Motion (XD 8000)?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ulrichINJECT CT Motion (XD 8000)?

The FDA product code for ulrichINJECT CT Motion (XD 8000) is IZQ.

Ulrich GmbH & Co. KG를 신청인으로 등재한 기타 기록

K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)K210541ulrichINJECT CT motion K202227Artus™ 경추판 시스템 K192872ulrichINJECT CT Motion

11개 장치 모두 보기 →

관련 기기 (코드: IZQ)

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