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FDA 510(k)

華星液晶螢幕 HMD2C21A、HMD4C27S、HMD6C30D

K 號：K222208 · 2022-11-17

申請人Qingdao Hisense Medical Equipment Co., Ltd.
決定日期2022-11-17
產品代碼PGY
諮詢委員會RA
決定相當於

器材摘要

Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K222208. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D?

Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K222208.

When did Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D receive FDA 510(k) clearance?

Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D received FDA 510(k) clearance on 2022-11-17, under 510(k) number K222208.

Who is the listed applicant for Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D?

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

What is the FDA product code for Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D?

The FDA product code for Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D is PGY.

相關臨床試驗

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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 Qingdao Hisense Medical Equipment 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。

K233841HD80系列超聲診斷系統K233439HD60系列超音波診斷系統K222132華星液晶螢幕 HMD2G21S，HMD3G21SK221567LCD螢幕（HMD3C21S），LCD螢幕（HMD5G21S）K213862HD60系列超音波診斷系統K160347華星LDC監視器型號 HMD2G21/HMD3G21/HMD5G21

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相關器械（代碼：PGY）

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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