FDA 510(k)

Scooter

K-번호: K182471 · 2019-07-10

신청자Tianjin Kepler Vehicle Industry Co. , Ltd.

결정일2019-07-10

제품 코드INI

자문 위원회PM

결정Substantially Equivalent

기기 요약

Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Kepler Vehicle Industry Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K182471. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Scooter?

Scooter is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Tianjin Kepler Vehicle Industry Co. , Ltd.. The 510(k) number is K182471.

When did Scooter receive FDA 510(k) clearance?

Scooter received FDA 510(k) clearance on 2019-07-10, under 510(k) number K182471.

Who is the listed applicant for Scooter?

The FDA 510(k) record lists Tianjin Kepler Vehicle Industry Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Scooter?

The FDA product code for Scooter is INI.

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Scooter

기기 요약

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관련 임상시험

관련 기기 (코드: INI)

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