FDA 510(k)

CMS600P2 B型超聲診斷系統

K 號：K170856 · 2017-11-17

決定日期2017-11-17

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

CMS600P2 B-Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K170856. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CMS600P2 B-Ultrasound Diagnostic System?

CMS600P2 B-Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Contec Medical Systems Co.,Ltd. The 510(k) number is K170856.

When did CMS600P2 B-Ultrasound Diagnostic System receive FDA 510(k) clearance?

CMS600P2 B-Ultrasound Diagnostic System received FDA 510(k) clearance on 2017-11-17, under 510(k) number K170856.

Who is the listed applicant for CMS600P2 B-Ultrasound Diagnostic System?

The FDA 510(k) record lists Contec Medical Systems Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMS600P2 B-Ultrasound Diagnostic System?

The FDA product code for CMS600P2 B-Ultrasound Diagnostic System is IYO.

其他以 Contec Medical Systems Co.,Ltd 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。

K232893口袋胎兒多普勒 (CONTEC 10D)，口袋胎兒多普勒 (CONTEC 10E)，口袋胎兒多普勒 (CONTEC 10F)K232895B-Ultrasound 診斷系統 K232908顏色多普勒超音波診斷系統（CMS1700B），顏色多普勒超音波診斷系統（CMS1700C）K220245口袋胎兒多普勒（型號CONTEC10C和CONTEC10CL）K202757CONTEC08A 電子血壓計，CONTEC08C 電子血壓計，ABPM50 自動血壓監測器 K201980紅外線體溫計

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相關器械（代碼：IYO）

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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