FDA 510(k)

Navient 이미지 가이드 나비게이션 시스템 (955-NC-NC), 뇌수술

K-번호: K241327 · 2025-02-05

결정일2025-02-05

제품 코드HAW

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

결정Substantially Equivalent

기기 요약

Navient Image Guide Navigation System (955-NC-NC), Cranial is the device name listed in this FDA 510(k) record. The listed applicant is Claronav. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K241327. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Navient Image Guide Navigation System (955-NC-NC), Cranial?

Navient Image Guide Navigation System (955-NC-NC), Cranial is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is Claronav. The 510(k) number is K241327.

When did Navient Image Guide Navigation System (955-NC-NC), Cranial receive FDA 510(k) clearance?

Navient Image Guide Navigation System (955-NC-NC), Cranial received FDA 510(k) clearance on 2025-02-05, under 510(k) number K241327.

Who is the listed applicant for Navient Image Guide Navigation System (955-NC-NC), Cranial?

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

What is the FDA product code for Navient Image Guide Navigation System (955-NC-NC), Cranial?

The FDA product code for Navient Image Guide Navigation System (955-NC-NC), Cranial is HAW.

Claronav를 신청인으로 등재한 기타 기록

K243053네비언트 이미지 가이드드 네비게이션 시스템 (ENT) (955-NC-NC)

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