FDA 510(k)

TORPEDO Implant System®

K-번호: K230817 · 2024-01-19

결정일2024-01-19

제품 코드OUR

자문 위원회OR

결정Substantially Equivalent

기기 요약

TORPEDO Implant System® is the device name listed in this FDA 510(k) record. The listed applicant is Deltacor GmbH. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K230817. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TORPEDO Implant System®?

TORPEDO Implant System® is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Deltacor GmbH. The 510(k) number is K230817.

When did TORPEDO Implant System® receive FDA 510(k) clearance?

TORPEDO Implant System® received FDA 510(k) clearance on 2024-01-19, under 510(k) number K230817.

Who is the listed applicant for TORPEDO Implant System®?

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

What is the FDA product code for TORPEDO Implant System®?

The FDA product code for TORPEDO Implant System® is OUR.

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TORPEDO Implant System®

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OUR)

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