FDA 510(k)

ATS 5000 Automatic Tourniquet Instrument

K-번호: K202919 · 2021-05-20

신청자Mcewen and Associates Consulting , Ltd.

결정일2021-05-20

제품 코드KCY

자문 위원회SU

결정Substantially Equivalent

기기 요약

ATS 5000 Automatic Tourniquet Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Mcewen and Associates Consulting , Ltd.. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K202919. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ATS 5000 Automatic Tourniquet Instrument?

ATS 5000 Automatic Tourniquet Instrument is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Mcewen and Associates Consulting , Ltd.. The 510(k) number is K202919.

When did ATS 5000 Automatic Tourniquet Instrument receive FDA 510(k) clearance?

ATS 5000 Automatic Tourniquet Instrument received FDA 510(k) clearance on 2021-05-20, under 510(k) number K202919.

Who is the listed applicant for ATS 5000 Automatic Tourniquet Instrument?

The FDA 510(k) record lists Mcewen and Associates Consulting , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATS 5000 Automatic Tourniquet Instrument?

The FDA product code for ATS 5000 Automatic Tourniquet Instrument is KCY.

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ATS 5000 Automatic Tourniquet Instrument

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관련 임상시험

관련 기기 (코드: KCY)

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