FDA 510(k)

velocity 알파 고속 수술 드릴 시스템

K-번호: K253772 · 2026-03-06

결정일2026-03-06

제품 코드HBB

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

Velocity Alpha MR High Speed Surgical Drill System is the device name listed in this FDA 510(k) record. The listed applicant is Adeor Medical AG. It received FDA 510(k) clearance on 2026-03-06 under 510(k) number K253772. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Velocity Alpha MR High Speed Surgical Drill System?

Velocity Alpha MR High Speed Surgical Drill System is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Adeor Medical AG. The 510(k) number is K253772.

When did Velocity Alpha MR High Speed Surgical Drill System receive FDA 510(k) clearance?

Velocity Alpha MR High Speed Surgical Drill System received FDA 510(k) clearance on 2026-03-06, under 510(k) number K253772.

Who is the listed applicant for Velocity Alpha MR High Speed Surgical Drill System?

The FDA 510(k) record lists Adeor Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velocity Alpha MR High Speed Surgical Drill System?

The FDA product code for Velocity Alpha MR High Speed Surgical Drill System is HBB.

Adeor Medical AG를 신청인으로 등재한 기타 기록

K191479velocity 알파 고속 수술 드림 시스템 K191847Adeor Medical nxt 비stick 양극 히스테르스코프, Adeor Medical nxt 단용 비stick 양극 히스테르스코프

공식 출처

FDA 데이터베이스에서 보기 →

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