FDA 510(k)

3D 볼러스 소프트웨어

K-번호: K180289 · 2018-07-10

결정일2018-07-10

제품 코드MUJ

자문 위원회RA

결정Substantially Equivalent

기기 요약

3D Bolus Software is the device name listed in this FDA 510(k) record. The listed applicant is 3D Bolus, Inc.. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K180289. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 3D Bolus Software?

3D Bolus Software is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is 3D Bolus, Inc.. The 510(k) number is K180289.

When did 3D Bolus Software receive FDA 510(k) clearance?

3D Bolus Software received FDA 510(k) clearance on 2018-07-10, under 510(k) number K180289.

Who is the listed applicant for 3D Bolus Software?

The FDA 510(k) record lists 3D Bolus, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D Bolus Software?

The FDA product code for 3D Bolus Software is MUJ.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

3D 볼러스 소프트웨어

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MUJ)

공식 출처