FDA 510(k)

이상형 분석 및 수정 소프트웨어 (DACS) 및 장비

K-번호: K180539 · 2018-08-13

신청자Arrowhead Medical Device Technologies, LLC

결정일2018-08-13

제품 코드OSN

자문 위원회OR

결정Substantially Equivalent

기기 요약

Deformity Analysis and Correction Software (DACS) and Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Arrowhead Medical Device Technologies, LLC. It received FDA 510(k) clearance on 2018-08-13 under 510(k) number K180539. The device is classified under product code OSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Deformity Analysis and Correction Software (DACS) and Instrumentation?

Deformity Analysis and Correction Software (DACS) and Instrumentation is a medical device that received FDA 510(k) clearance on 2018-08-13. The listed applicant is Arrowhead Medical Device Technologies, LLC. The 510(k) number is K180539.

When did Deformity Analysis and Correction Software (DACS) and Instrumentation receive FDA 510(k) clearance?

Deformity Analysis and Correction Software (DACS) and Instrumentation received FDA 510(k) clearance on 2018-08-13, under 510(k) number K180539.

Who is the listed applicant for Deformity Analysis and Correction Software (DACS) and Instrumentation?

The FDA 510(k) record lists Arrowhead Medical Device Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deformity Analysis and Correction Software (DACS) and Instrumentation?

The FDA product code for Deformity Analysis and Correction Software (DACS) and Instrumentation is OSN.

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이상형 분석 및 수정 소프트웨어 (DACS) 및 장비

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OSN)

공식 출처