FDA 510(k)

PureLift Pro Edition

K-번호: K230506 · 2023-06-21

결정일2023-06-21

제품 코드NFO

자문 위원회NE

결정Substantially Equivalent

기기 요약

PureLift Pro Edition is the device name listed in this FDA 510(k) record. The listed applicant is Xtreem Pulse. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K230506. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PureLift Pro Edition?

PureLift Pro Edition is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Xtreem Pulse. The 510(k) number is K230506.

When did PureLift Pro Edition receive FDA 510(k) clearance?

PureLift Pro Edition received FDA 510(k) clearance on 2023-06-21, under 510(k) number K230506.

Who is the listed applicant for PureLift Pro Edition?

The FDA 510(k) record lists Xtreem Pulse as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PureLift Pro Edition?

The FDA product code for PureLift Pro Edition is NFO.

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PureLift Pro Edition

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: NFO)

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