FDA 510(k)

CT-STOR

K-번호: K201789 · 2021-09-20

결정일2021-09-20

제품 코드NDS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

CT-STOR is the device name listed in this FDA 510(k) record. The listed applicant is Energy Delivery Solutions. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K201789. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CT-STOR?

CT-STOR is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Energy Delivery Solutions. The 510(k) number is K201789.

When did CT-STOR receive FDA 510(k) clearance?

CT-STOR received FDA 510(k) clearance on 2021-09-20, under 510(k) number K201789.

Who is the listed applicant for CT-STOR?

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

What is the FDA product code for CT-STOR?

The FDA product code for CT-STOR is NDS.

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기기 요약

자주 묻는 질문

관련 기기 (코드: NDS)

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