FDA 510(k)

LSSA (NP-200)

K 號：K252495 · 2026-04-03

決定日期2026-04-03

產品代碼QPB

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

LSSA (NP-200) is the device name listed in this FDA 510(k) record. The listed applicant is Newpong Co., Ltd.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K252495. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LSSA (NP-200)?

LSSA (NP-200) is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Newpong Co., Ltd.. The 510(k) number is K252495.

When did LSSA (NP-200) receive FDA 510(k) clearance?

LSSA (NP-200) received FDA 510(k) clearance on 2026-04-03, under 510(k) number K252495.

Who is the listed applicant for LSSA (NP-200)?

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

What is the FDA product code for LSSA (NP-200)?

The FDA product code for LSSA (NP-200) is QPB.

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官方來源

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