FDA 510(k)

ZOLL 心電圖分析軟體

K 號：K182093 · 2019-01-28

決定日期2019-01-28

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

ZOLL ECG Analysis Software is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Manufacturing Corporation. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K182093. 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 ZOLL ECG Analysis Software?

ZOLL ECG Analysis Software is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Zoll Manufacturing Corporation. The 510(k) number is K182093.

When did ZOLL ECG Analysis Software receive FDA 510(k) clearance?

ZOLL ECG Analysis Software received FDA 510(k) clearance on 2019-01-28, under 510(k) number K182093.

Who is the listed applicant for ZOLL ECG Analysis Software?

The FDA 510(k) record lists Zoll Manufacturing Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOLL ECG Analysis Software?

The FDA product code for ZOLL ECG Analysis Software is DPS.

其他以 Zoll Manufacturing Corporation 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。

K190939ZOLL心律管理系統 K172510µCor 心衰竭與心律不整管理系統

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。

K254255S-Patch 心臟AIWellysis Corp.K252463SE-1202系列心電圖儀（型號：SE-1202，SE-1202E）Edan Instruments, Inc.K251670MAC 7 靜息心電圖分析系統Ge Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs 霍爾特平台Philips France Commercial

官方來源

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