FDA 510(k)

Restore PACS

K-번호: K162141 · 2016-09-02

신청자Xian Wingspan Electronic Technology Co., Ltd.

결정일2016-09-02

제품 코드LLZ

자문 위원회RA

결정Substantially Equivalent

기기 요약

Restore PACS is the device name listed in this FDA 510(k) record. The listed applicant is Xian Wingspan Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K162141. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Restore PACS?

Restore PACS is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Xian Wingspan Electronic Technology Co., Ltd.. The 510(k) number is K162141.

When did Restore PACS receive FDA 510(k) clearance?

Restore PACS received FDA 510(k) clearance on 2016-09-02, under 510(k) number K162141.

Who is the listed applicant for Restore PACS?

The FDA 510(k) record lists Xian Wingspan Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Restore PACS?

The FDA product code for Restore PACS is LLZ.

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Restore PACS

기기 요약

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관련 임상시험

관련 기기 (코드: LLZ)

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