FDA 510(k)

BEMER Classic Set, BEMER Pro-Set

K 號：K151834 · 2017-02-22

決定日期2017-02-22

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

BEMER Classic Set, BEMER Pro-Set is the device name listed in this FDA 510(k) record. The listed applicant is Bemer Int AG. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K151834. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BEMER Classic Set, BEMER Pro-Set?

BEMER Classic Set, BEMER Pro-Set is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Bemer Int AG. The 510(k) number is K151834.

When did BEMER Classic Set, BEMER Pro-Set receive FDA 510(k) clearance?

BEMER Classic Set, BEMER Pro-Set received FDA 510(k) clearance on 2017-02-22, under 510(k) number K151834.

Who is the listed applicant for BEMER Classic Set, BEMER Pro-Set?

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

What is the FDA product code for BEMER Classic Set, BEMER Pro-Set?

The FDA product code for BEMER Classic Set, BEMER Pro-Set is NGX.

其他以 Bemer Int AG 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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