Breezeway II
K 號：K210627 · 2021-06-03
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器材摘要
Breezeway II is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 2021-06-03 under 510(k) number K210627. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Breezeway II?
Breezeway II is a medical device that received FDA 510(k) clearance on 2021-06-03. The listed applicant is Oscor, Inc.. The 510(k) number is K210627.
When did Breezeway II receive FDA 510(k) clearance?
Breezeway II received FDA 510(k) clearance on 2021-06-03, under 510(k) number K210627.
Who is the listed applicant for Breezeway II?
The FDA 510(k) record lists Oscor, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Breezeway II?
The FDA product code for Breezeway II is DYB.
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相關器械（代碼：DYB）
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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