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FDA 510(k)

醫網公司鼓勵式肺功能儀 - 呼吸計程式

K 號:K160837 · 2017-02-23

申請人Medinet Srl
決定日期2017-02-23
產品代碼BWF
諮詢委員會AN
決定相當於

器材摘要

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Medinet Srl. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K160837. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM?

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Medinet Srl. The 510(k) number is K160837.

When did MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM receive FDA 510(k) clearance?

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM received FDA 510(k) clearance on 2017-02-23, under 510(k) number K160837.

Who is the listed applicant for MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM?

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

What is the FDA product code for MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM?

The FDA product code for MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM is BWF.

相關臨床試驗

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相關器械(代碼:BWF)

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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