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FDA 510(k)

SPRINT神經系統系統

K 號:K240974 · 2026-04-14

決定日期2026-04-14
產品代碼SCN
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

SPRINT PNS System is the device name listed in this FDA 510(k) record. The listed applicant is Spr Therapeutics, Inc.. It received FDA 510(k) clearance on 2026-04-14 under 510(k) number K240974. The device is classified under product code SCN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPRINT PNS System?

SPRINT PNS System is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Spr Therapeutics, Inc.. The 510(k) number is K240974.

When did SPRINT PNS System receive FDA 510(k) clearance?

SPRINT PNS System received FDA 510(k) clearance on 2026-04-14, under 510(k) number K240974.

Who is the listed applicant for SPRINT PNS System?

The FDA 510(k) record lists Spr Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPRINT PNS System?

The FDA product code for SPRINT PNS System is SCN.

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其他以 Spr Therapeutics, Inc. 為申請人之記錄

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官方來源

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