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FDA 510(k)

寶比萊兒嬰兒血壓監測器

K 號:K223873 · 2023-09-29

申請人Pyrames, Inc.
決定日期2023-09-29
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Boppli Infant Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Pyrames, Inc.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K223873. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Boppli Infant Blood Pressure Monitor?

Boppli Infant Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Pyrames, Inc.. The 510(k) number is K223873.

When did Boppli Infant Blood Pressure Monitor receive FDA 510(k) clearance?

Boppli Infant Blood Pressure Monitor received FDA 510(k) clearance on 2023-09-29, under 510(k) number K223873.

Who is the listed applicant for Boppli Infant Blood Pressure Monitor?

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

What is the FDA product code for Boppli Infant Blood Pressure Monitor?

The FDA product code for Boppli Infant Blood Pressure Monitor is DXN.

相關臨床試驗

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相關器械(代碼:DXN)

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。

官方來源

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