免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

野生獵犬PE外科隔離袍開背款，野生獵犬PE外科隔離袍全背款

K 號：K202310 · 2021-01-29

申請人Wildcat Ppe, LLC
決定日期2021-01-29
產品代碼FYC
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is the device name listed in this FDA 510(k) record. The listed applicant is Wildcat Ppe, LLC. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K202310. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Wildcat Ppe, LLC. The 510(k) number is K202310.

When did Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back receive FDA 510(k) clearance?

Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back received FDA 510(k) clearance on 2021-01-29, under 510(k) number K202310.

Who is the listed applicant for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

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

What is the FDA product code for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back?

The FDA product code for Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back is FYC.

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：FYC）

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。

K232849Halyard 三層 AAMI 3 隔離衣，L，藍色（54310），Halyard 三層 AAMI 3 隔離衣，超加大，藍色（54311）Owens & Minor (O&M) Halyard, Inc.K230135Copioumed 化療隔離袍Copioumed International, Inc.K223467一次性隔離衣Nanning Tecbod Biological Technology Co., Ltd.K223304一次性隔離袍（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Technology Co., Ltd.K223411一次性隔離袍（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI等級3隔離袍Paneffort, LLC

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。

↑