FDA 510(k)

華星液晶螢幕 HMD2G21S，HMD3G21S

K 號：K222132 · 2022-11-08

申請人Qingdao Hisense Medical Equipment Co., Ltd.

決定日期2022-11-08

產品代碼PGY

諮詢委員會RA

決定相當於

器材摘要

Hisense LCD monitor HMD2G21S, HMD3G21S 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 2022-11-08 under 510(k) number K222132. 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 HMD2G21S, HMD3G21S?

Hisense LCD monitor HMD2G21S, HMD3G21S is a medical device that received FDA 510(k) clearance on 2022-11-08. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K222132.

When did Hisense LCD monitor HMD2G21S, HMD3G21S receive FDA 510(k) clearance?

Hisense LCD monitor HMD2G21S, HMD3G21S received FDA 510(k) clearance on 2022-11-08, under 510(k) number K222132.

Who is the listed applicant for Hisense LCD monitor HMD2G21S, HMD3G21S?

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 HMD2G21S, HMD3G21S?

The FDA product code for Hisense LCD monitor HMD2G21S, HMD3G21S is PGY.

其他以 Qingdao Hisense Medical Equipment Co., Ltd. 為申請人之記錄

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K233841HD80系列超聲診斷系統 K233439HD60系列超音波診斷系統 K222208華星液晶螢幕 HMD2C21A、HMD4C27S、HMD6C30D K221567LCD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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