FDA 510(k)

手機膀胱掃描儀 - PBSV5.1

K 號：K191307 · 2019-06-05

申請人Mianyang Meike Electronic Equipment Co., Ltd.

決定日期2019-06-05

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

Palm Bladder Scanner - PBSV5.1 is the device name listed in this FDA 510(k) record. The listed applicant is Mianyang Meike Electronic Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-06-05 under 510(k) number K191307. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Palm Bladder Scanner - PBSV5.1?

Palm Bladder Scanner - PBSV5.1 is a medical device that received FDA 510(k) clearance on 2019-06-05. The listed applicant is Mianyang Meike Electronic Equipment Co., Ltd.. The 510(k) number is K191307.

When did Palm Bladder Scanner - PBSV5.1 receive FDA 510(k) clearance?

Palm Bladder Scanner - PBSV5.1 received FDA 510(k) clearance on 2019-06-05, under 510(k) number K191307.

Who is the listed applicant for Palm Bladder Scanner - PBSV5.1?

The FDA 510(k) record lists Mianyang Meike Electronic Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palm Bladder Scanner - PBSV5.1?

The FDA product code for Palm Bladder Scanner - PBSV5.1 is IYO.

其他以 Mianyang Meike Electronic Equipment Co., 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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