FDA 510(k)

RTHawk, 心視野心臟套件

K 號：K212233 · 2021-10-05

決定日期2021-10-05

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

RTHawk, HeartVista Cardiac Package is the device name listed in this FDA 510(k) record. The listed applicant is Heartvista, Inc.. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K212233. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RTHawk, HeartVista Cardiac Package?

RTHawk, HeartVista Cardiac Package is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Heartvista, Inc.. The 510(k) number is K212233.

When did RTHawk, HeartVista Cardiac Package receive FDA 510(k) clearance?

RTHawk, HeartVista Cardiac Package received FDA 510(k) clearance on 2021-10-05, under 510(k) number K212233.

Who is the listed applicant for RTHawk, HeartVista Cardiac Package?

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

What is the FDA product code for RTHawk, HeartVista Cardiac Package?

The FDA product code for RTHawk, HeartVista Cardiac Package is LNH.

其他以 Heartvista, Inc. 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。

K183274RTHawk, 心視野心臟套件 K170090RTHawk, 心視野心臟套件 K153740RTHawk, 心視野心臟套件

相關器械（代碼：LNH）

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。

K261283APERTO Lucent MRI 系統Fujifilm Corporation K261758擁抱視覺新生兒MRI系統Aspect Imaging, Ltd.K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® 輕便式磁共振成像® 系統Hyperfine, Inc.K254250MagicScan-1.5，綠色MR寧靜1.5TXingaoyi Medical Equipment Co.,Ltd K253808空氣偵探 DLGE Medical Systems

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。