FDA 510(k)

3Shape Implant Studio

K-번호: K202256 · 2020-09-09

결정일2020-09-09

제품 코드LLZ

자문 위원회RA

결정Substantially Equivalent

기기 요약

3Shape Implant Studio is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape Medical A/S. It received FDA 510(k) clearance on 2020-09-09 under 510(k) number K202256. 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 3Shape Implant Studio?

3Shape Implant Studio is a medical device that received FDA 510(k) clearance on 2020-09-09. The listed applicant is 3Shape Medical A/S. The 510(k) number is K202256.

When did 3Shape Implant Studio receive FDA 510(k) clearance?

3Shape Implant Studio received FDA 510(k) clearance on 2020-09-09, under 510(k) number K202256.

Who is the listed applicant for 3Shape Implant Studio?

The FDA 510(k) record lists 3Shape Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3Shape Implant Studio?

The FDA product code for 3Shape Implant Studio is LLZ.

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3Shape Implant Studio

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LLZ)

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