貓鼬5
K 號:K213098 · 2023-07-20
廣告
器材摘要
Panther 5 is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medical Devices. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K213098. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Panther 5?
Panther 5 is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is Origin Medical Devices. The 510(k) number is K213098.
When did Panther 5 receive FDA 510(k) clearance?
Panther 5 received FDA 510(k) clearance on 2023-07-20, under 510(k) number K213098.
Who is the listed applicant for Panther 5?
The FDA 510(k) record lists Origin Medical Devices as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Panther 5?
The FDA product code for Panther 5 is CBK.
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:CBK)
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。
K253647Evita (V800);Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus 多功能Iconic Solutions by Murcia, SLK251888VPAP兒童臉部口罩Hsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV醫院通氣全臉罩,適用單肢循環 – 尺寸A (ONIV117A);F&P OptiNIV醫院通氣全臉罩,適用單肢循環 – 尺寸B (ONIV117B);F&P OptiNIV醫院通氣全臉罩,適用單肢循環 – 尺寸C (ONIV117C);F&P OptiNIV ONIV117-F醫院通氣全臉罩,可選配呼氣過濾器,適用單肢循環 - 尺寸A (ONIV117A-F);F&P OptiNIV ONIV117-F醫院通氣全臉罩Fisher & Paykel Healthcare, Ltd.K243767SV600、SV800 呼吸器Shenzhen Mindray Bio-Medical Electronics 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