FDA 510(k)

수술용 마스크 (정화된), 수술용 마스크 (정화되지 않은)

K-번호: K202843 · 2021-01-12

신청자B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

결정일2021-01-12

제품 코드FXX

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

결정대체적으로 동일

기기 요약

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. It received FDA 510(k) clearance on 2021-01-12 under 510(k) number K202843. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)?

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is a medical device that received FDA 510(k) clearance on 2021-01-12. The listed applicant is B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. The 510(k) number is K202843.

When did Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) receive FDA 510(k) clearance?

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) received FDA 510(k) clearance on 2021-01-12, under 510(k) number K202843.

Who is the listed applicant for Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)?

The FDA 510(k) record lists B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)?

The FDA product code for Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) is FXX.

B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.를 신청인으로 등재한 기타 기록

K202706수술복(정화된), 수술복(정화되지 않은)

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