FDA 510(k)

의료 수술 마스크 (모델: ZKM-U01(비정화형 17.5cm×9.5cm))

K-번호: K212460 · 2021-11-05

신청자Guangzhou Zhengkang Medical Equipment Co.,Ltd

결정일2021-11-05

제품 코드FXX

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

결정대체적으로 동일

기기 요약

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Zhengkang Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K212460. 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 Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Guangzhou Zhengkang Medical Equipment Co.,Ltd. The 510(k) number is K212460.

When did Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) receive FDA 510(k) clearance?

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) received FDA 510(k) clearance on 2021-11-05, under 510(k) number K212460.

Who is the listed applicant for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

The FDA 510(k) record lists Guangzhou Zhengkang Medical Equipment Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))?

The FDA product code for Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) is FXX.

Guangzhou Zhengkang Medical Equipment Co.,Ltd를 신청인으로 등재한 기타 기록

K222204의료 수술 마스크

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