FDA 510(k)

Sparrow 飛昇

K 號：K251246 · 2025-08-25

決定日期2025-08-25

產品代碼PZR

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

Sparrow Ascent is the device name listed in this FDA 510(k) record. The listed applicant is Spark Biomedical, Inc.. It received FDA 510(k) clearance on 2025-08-25 under 510(k) number K251246. The device is classified under product code PZR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sparrow Ascent?

Sparrow Ascent is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Spark Biomedical, Inc.. The 510(k) number is K251246.

When did Sparrow Ascent receive FDA 510(k) clearance?

Sparrow Ascent received FDA 510(k) clearance on 2025-08-25, under 510(k) number K251246.

Who is the listed applicant for Sparrow Ascent?

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

What is the FDA product code for Sparrow Ascent?

The FDA product code for Sparrow Ascent is PZR.

其他以 Spark Biomedical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K230796Sparrow 飛昇 K201873Sparrow治療系統

相關器械（代碼：PZR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K233166NET Recovery Corp/NET 製備医療設備監管文本Net Recovery K230796Sparrow 飛昇Spark Biomedical, Inc.K221231藥物緩解 v1Dyansys, Inc.K211971藥物緩解 v1Dyansys, Inc.K201873Sparrow治療系統Spark Biomedical, Inc.K173861藥物緩解Dyansys, Inc.

官方來源

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