免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

SPECTRA 一次性單腔顯影注射麻醉導針

K 號：K151069 · 2016-02-05

申請人Spectra Medical Devices, Inc.
決定日期2016-02-05
產品代碼BSP
諮詢委員會AN
決定相當於

器材摘要

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is the device name listed in this FDA 510(k) record. The listed applicant is Spectra Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K151069. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Spectra Medical Devices, Inc.. The 510(k) number is K151069.

When did SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle receive FDA 510(k) clearance?

SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle received FDA 510(k) clearance on 2016-02-05, under 510(k) number K151069.

Who is the listed applicant for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

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

What is the FDA product code for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle?

The FDA product code for SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is BSP.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：BSP）

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。

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM；SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® 标準 (LUER/NRFit®) 腰椎穿刺PAJUNK GmbH MedizintechnologieK243525SonoTAP 及 SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE®標準（LUER/NRFit®）麻醉學PAJUNK GmbH MedizintechnologieK241954SonoBlock；SonoBlock IIPAJUNK GmbH Medizintechnologie

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑