FDA 510(k)

BMR 1900 體育器材規範文本

K 號：K223361 · 2023-06-10

決定日期2023-06-10

產品代碼DTN

諮詢委員會履歷

決定相當於

器材摘要

BMR 1900 PHISIO is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2023-06-10 under 510(k) number K223361. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BMR 1900 PHISIO?

BMR 1900 PHISIO is a medical device that received FDA 510(k) clearance on 2023-06-10. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K223361.

When did BMR 1900 PHISIO receive FDA 510(k) clearance?

BMR 1900 PHISIO received FDA 510(k) clearance on 2023-06-10, under 510(k) number K223361.

Who is the listed applicant for BMR 1900 PHISIO?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BMR 1900 PHISIO?

The FDA product code for BMR 1900 PHISIO is DTN.

其他以 Sorin Group Italia S.R.L. 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。

K253671雙階段靜脈針管 K251783啟動HCR及HCR DUAL心臟切開儲存器 K253616ProtekDilate 血管通路套件 K250610Easyflow (103-200; 103-300)；Easyflow Duo (103-210; 103-310)K250150VANGUARD 血液心肺機系統（Vanguard 4:1 血液心肺機組合）；VANGUARD 血液心肺機系統（Vanguard 4:1 血液心肺機組合帶分流）；VANGUARD 血液心肺機系統（Vanguard 4:1 血液心肺機組合迷你版）K243264DHF 0.2 血濃度濃縮器（DHF 02）；DHF 0.6 血濃度濃縮器（DHF 06）；SH 14 血濃度濃縮器（SH 14）

查看所有 24 項裝置 →

相關器械（代碼：DTN）

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。

K251783啟動HCR及HCR DUAL心臟切開儲存器Sorin Group Italia S.R.L.K241206量子灌流混合系統Spectrum Medical S.R.L.K241053MVR™ 靜脈蓄血袋800毫升；MVR™ 静脈蓄血袋1600毫升；MVR™ 靜脈蓄血袋配Cortiva™ 生物活性表面800毫升；MVR™ 静脈蓄血袋配Cortiva™ 生物活性表面1600毫升Medtronic Cardiac Surgery K170583Intersept過濾式心內切術容器，配Cortiva生物活性表面Medtronic, Inc.K161733INSPiRE SVR 1200, INSPiRE 6F C, INSPiRE 8F CSorin Group Italia S.R.L.

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。