Thora-guard 系統
K 號：K181667 · 2018-11-29
廣告
器材摘要
Thoraguard System is the device name listed in this FDA 510(k) record. The listed applicant is Centese, Inc.. It received FDA 510(k) clearance on 2018-11-29 under 510(k) number K181667. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Thoraguard System?
Thoraguard System is a medical device that received FDA 510(k) clearance on 2018-11-29. The listed applicant is Centese, Inc.. The 510(k) number is K181667.
When did Thoraguard System receive FDA 510(k) clearance?
Thoraguard System received FDA 510(k) clearance on 2018-11-29, under 510(k) number K181667.
Who is the listed applicant for Thoraguard System?
The FDA 510(k) record lists Centese, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Thoraguard System?
The FDA product code for Thoraguard System is BTA.
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。
相關器械（代碼：BTA）
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。
K253629Momcozy 鼻吸器 (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134嬰兒鼻吸器（BN006、BN006-A、BN006-B、BN006-C、BN006-D、BN02；BN008、BN008-A、BN008-B、BN008-C、BN008-D、BC-021）Shenzhen Root Innovation Technology Co., Ltd.K260892吸引泵（SU-90）Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473電動鼻吸器（BC027、BC030、BC033、BC035、BC035B）Shenzhen Kingboom Technology Co., Ltd.K253107電動鼻吸器（DT10及DT50，DX80，DX85，DX86及DX90）Shenzhen Dongjiang Technology Co., Ltd.K260147電動鼻吸器（BC026、BC025、BC023、BC028、BC029、BC036）Shenzhen Kingboom Technology Co., Ltd.
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。
廣告