FDA 510(k)

HI-EMT 魔形醫療設備

K 號：K230024 · 2023-09-06

申請人Beijing Sano Laser S&T Development Co.,Ltd

決定日期2023-09-06

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

HI-EMT MAGSHAPE is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. It received FDA 510(k) clearance on 2023-09-06 under 510(k) number K230024. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HI-EMT MAGSHAPE?

HI-EMT MAGSHAPE is a medical device that received FDA 510(k) clearance on 2023-09-06. The listed applicant is Beijing Sano Laser S&T Development Co.,Ltd. The 510(k) number is K230024.

When did HI-EMT MAGSHAPE receive FDA 510(k) clearance?

HI-EMT MAGSHAPE received FDA 510(k) clearance on 2023-09-06, under 510(k) number K230024.

Who is the listed applicant for HI-EMT MAGSHAPE?

The FDA 510(k) record lists Beijing Sano Laser S&T Development Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-EMT MAGSHAPE?

The FDA product code for HI-EMT MAGSHAPE is NGX.

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官方來源

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