FDA 510(k)桃子2, 桃子2雙,桃子2行
K 號:K231977 · 2023-09-25
決定日期2023-09-25
產品代碼OHT
諮詢委員會SU
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決定相當於
器材摘要
PEACH 2, PEACH 2 Duo, PEACH 2 go is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K231977. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PEACH 2, PEACH 2 Duo, PEACH 2 go?
PEACH 2, PEACH 2 Duo, PEACH 2 go is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Foreo, Inc.. The 510(k) number is K231977.
When did PEACH 2, PEACH 2 Duo, PEACH 2 go receive FDA 510(k) clearance?
PEACH 2, PEACH 2 Duo, PEACH 2 go received FDA 510(k) clearance on 2023-09-25, under 510(k) number K231977.
Who is the listed applicant for PEACH 2, PEACH 2 Duo, PEACH 2 go?
The FDA 510(k) record lists Foreo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PEACH 2, PEACH 2 Duo, PEACH 2 go?
The FDA product code for PEACH 2, PEACH 2 Duo, PEACH 2 go is OHT.
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其他以 Foreo, Inc. 為申請人之記錄
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相關器械(代碼:OHT)
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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