FDA 510(k)

ProCell 수술용 체인지폰-혈액 회수 단위

K-번호: K193361 · 2020-06-01

결정일2020-06-01

제품 코드CAC

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정대체적으로 동일

기기 요약

ProCell Surgical Sponge-Blood Recovery Unit is the device name listed in this FDA 510(k) record. The listed applicant is Procell Surgical, Inc.. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K193361. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ProCell Surgical Sponge-Blood Recovery Unit?

ProCell Surgical Sponge-Blood Recovery Unit is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Procell Surgical, Inc.. The 510(k) number is K193361.

When did ProCell Surgical Sponge-Blood Recovery Unit receive FDA 510(k) clearance?

ProCell Surgical Sponge-Blood Recovery Unit received FDA 510(k) clearance on 2020-06-01, under 510(k) number K193361.

Who is the listed applicant for ProCell Surgical Sponge-Blood Recovery Unit?

The FDA 510(k) record lists Procell Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProCell Surgical Sponge-Blood Recovery Unit?

The FDA product code for ProCell Surgical Sponge-Blood Recovery Unit is CAC.

공식 출처

FDA 데이터베이스에서 보기 →

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

ProCell 수술용 체인지폰-혈액 회수 단위

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: CAC)

공식 출처