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FDA 510(k)

前鋒一次性PVC復甦器，前鋒一次性PEEP閥，前鋒一次性壓力計

K 號：K170663 · 2018-05-11

申請人Foremount Enterprise Co., Ltd.
決定日期2018-05-11
產品代碼BTM
諮詢委員會AN
決定相當於

器材摘要

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer is the device name listed in this FDA 510(k) record. The listed applicant is Foremount Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K170663. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer?

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Foremount Enterprise Co., Ltd.. The 510(k) number is K170663.

When did Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer receive FDA 510(k) clearance?

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer received FDA 510(k) clearance on 2018-05-11, under 510(k) number K170663.

Who is the listed applicant for Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer?

The FDA 510(k) record lists Foremount Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer?

The FDA product code for Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer is BTM.

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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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