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FDA 510(k)

Zyter RPM

K 號：K212622 · 2022-02-11

申請人Zyter, Inc.
決定日期2022-02-11
產品代碼MSX
諮詢委員會履歷
決定相當於

器材摘要

Zyter RPM is the device name listed in this FDA 510(k) record. The listed applicant is Zyter, Inc.. It received FDA 510(k) clearance on 2022-02-11 under 510(k) number K212622. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zyter RPM?

Zyter RPM is a medical device that received FDA 510(k) clearance on 2022-02-11. The listed applicant is Zyter, Inc.. The 510(k) number is K212622.

When did Zyter RPM receive FDA 510(k) clearance?

Zyter RPM received FDA 510(k) clearance on 2022-02-11, under 510(k) number K212622.

Who is the listed applicant for Zyter RPM?

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

What is the FDA product code for Zyter RPM?

The FDA product code for Zyter RPM is MSX.

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

相關器械（代碼：MSX）

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。

K261287數位統計護理Ascom Ums Srl UnipersonaleK260211儀表板（P007000）Hill-Rom, Inc.K261367柯薩諾 CardioWatch 287-2 系統Corsano Health B.V.K253654IntelliVue測量架6000（867317）Philips Medizin Systeme Böblingen GmbHK243270虎連接警報管理TigerconnectK242728BeneVision 中央監控系統Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

官方來源

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