FDA 510(k)

PureLift Pro Edition

K番号: K230506 · 2023-06-21

決定日2023-06-21

製品コードNFO

諮問委員会NE

決定Substantially Equivalent

医療機器の概要

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.

よくある質問

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

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：NFO）

公式ソース