FDA 510(k)

TraumaCad Mobile Release 2.0

K-번호: K160001 · 2016-02-12

결정일2016-02-12

제품 코드LLZ

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

TraumaCad Mobile Release 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Voyant Health, Ltd.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K160001. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TraumaCad Mobile Release 2.0?

TraumaCad Mobile Release 2.0 is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Voyant Health, Ltd.. The 510(k) number is K160001.

When did TraumaCad Mobile Release 2.0 receive FDA 510(k) clearance?

TraumaCad Mobile Release 2.0 received FDA 510(k) clearance on 2016-02-12, under 510(k) number K160001.

Who is the listed applicant for TraumaCad Mobile Release 2.0?

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

What is the FDA product code for TraumaCad Mobile Release 2.0?

The FDA product code for TraumaCad Mobile Release 2.0 is LLZ.

공식 출처

FDA 데이터베이스에서 보기 →

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

TraumaCad Mobile Release 2.0

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LLZ)

공식 출처