FDA 510(k)

SRX手持式多普勒，DMX手持式多普勒，產科探頭，血管探頭

K 號：K183574 · 2019-09-06

決定日期2019-09-06

產品代碼DPW

諮詢委員會履歷

決定相當於

器材摘要

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare , Ltd.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K183574. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Huntleigh Healthcare , Ltd.. The 510(k) number is K183574.

When did SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes receive FDA 510(k) clearance?

SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes received FDA 510(k) clearance on 2019-09-06, under 510(k) number K183574.

Who is the listed applicant for SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

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

What is the FDA product code for SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes?

The FDA product code for SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes is DPW.

其他以 Huntleigh Healthcare , Ltd. 為申請人之記錄

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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相關器械（代碼：DPW）

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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