FDA 510(k)

야드웨일드 PE 수술隔離복 개방형, 야드웨일드 PE 수술隔離복 완전형

K-번호: K202310 · 2021-01-29

결정일2021-01-29

제품 코드FYC

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is the device name listed in this FDA 510(k) record. The listed applicant is Wildcat Ppe, LLC. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K202310. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Wildcat Ppe, LLC. The 510(k) number is K202310.

When did Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back receive FDA 510(k) clearance?

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back received FDA 510(k) clearance on 2021-01-29, under 510(k) number K202310.

Who is the listed applicant for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

The FDA 510(k) record lists Wildcat Ppe, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

The FDA product code for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is FYC.

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FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

야드웨일드 PE 수술隔離복 개방형, 야드웨일드 PE 수술隔離복 완전형

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FYC)

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