1L Flexoval®瓶无菌吸入用水。
K 號：K223551 · 2023-08-03
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器材摘要
Sterile Water for Inhalation in 1L Flexoval ® bottles. is the device name listed in this FDA 510(k) record. The listed applicant is Hometa, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K223551. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sterile Water for Inhalation in 1L Flexoval ® bottles.?
Sterile Water for Inhalation in 1L Flexoval ® bottles. is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Hometa, Inc.. The 510(k) number is K223551.
When did Sterile Water for Inhalation in 1L Flexoval ® bottles. receive FDA 510(k) clearance?
Sterile Water for Inhalation in 1L Flexoval ® bottles. received FDA 510(k) clearance on 2023-08-03, under 510(k) number K223551.
Who is the listed applicant for Sterile Water for Inhalation in 1L Flexoval ® bottles.?
The FDA 510(k) record lists Hometa, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles.?
The FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles. is BTT.
相關臨床試驗
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相關器械（代碼：BTT）
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。
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官方來源
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