極冷波護理設備
K 號：K183702 · 2019-03-01
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器材摘要
Polar Care Wave is the device name listed in this FDA 510(k) record. The listed applicant is Breg, Inc.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K183702. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Polar Care Wave?
Polar Care Wave is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Breg, Inc.. The 510(k) number is K183702.
When did Polar Care Wave receive FDA 510(k) clearance?
Polar Care Wave received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183702.
Who is the listed applicant for Polar Care Wave?
The FDA 510(k) record lists Breg, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Polar Care Wave?
The FDA product code for Polar Care Wave is IRP.
相關臨床試驗
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相關器械（代碼：IRP）
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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