FDA 510(k)

Tellos ISQ Buddy

K-번호: K143445 · 2016-01-07

결정일2016-01-07

제품 코드EKX

자문 위원회DE

결정Substantially Equivalent

기기 요약

Tellos ISQ Buddy is the device name listed in this FDA 510(k) record. The listed applicant is Tellos Medical AB. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K143445. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Tellos ISQ Buddy?

Tellos ISQ Buddy is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Tellos Medical AB. The 510(k) number is K143445.

When did Tellos ISQ Buddy receive FDA 510(k) clearance?

Tellos ISQ Buddy received FDA 510(k) clearance on 2016-01-07, under 510(k) number K143445.

Who is the listed applicant for Tellos ISQ Buddy?

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

What is the FDA product code for Tellos ISQ Buddy?

The FDA product code for Tellos ISQ Buddy is EKX.

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Tellos ISQ Buddy

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: EKX)

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