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FDA 510(k)

Xscribe 压力運動測試系統，Q-Stress 压力運動測試系統

K 號：K152944 · 2016-01-06

申請人Mortara Instrument, Inc.
決定日期2016-01-06
產品代碼DPS
諮詢委員會履歷
決定相當於

器材摘要

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K152944. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems?

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K152944.

When did Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems receive FDA 510(k) clearance?

Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems received FDA 510(k) clearance on 2016-01-06, under 510(k) number K152944.

Who is the listed applicant for Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems?

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

What is the FDA product code for Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems?

The FDA product code for Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems is DPS.

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

其他以 Mortara Instrument, 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。

K182297調查員S2K173765檢查員病人監護儀K161517Mortara 調查員病人監護儀K161465心臟確認K160685調查員S4行動監視器K152626H3+ 霍爾特記錄儀

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相關器械（代碼：DPS）

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。

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官方來源

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