FDA 510(k)

Ballancer Gold, 1212

K 號：K190015 · 2019-03-25

決定日期2019-03-25

產品代碼IRP

諮詢委員會PM

決定相當於

器材摘要

Ballancer Gold, 1212 is the device name listed in this FDA 510(k) record. The listed applicant is Mego Afek AC , Ltd.. It received FDA 510(k) clearance on 2019-03-25 under 510(k) number K190015. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ballancer Gold, 1212?

Ballancer Gold, 1212 is a medical device that received FDA 510(k) clearance on 2019-03-25. The listed applicant is Mego Afek AC , Ltd.. The 510(k) number is K190015.

When did Ballancer Gold, 1212 receive FDA 510(k) clearance?

Ballancer Gold, 1212 received FDA 510(k) clearance on 2019-03-25, under 510(k) number K190015.

Who is the listed applicant for Ballancer Gold, 1212?

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

What is the FDA product code for Ballancer Gold, 1212?

The FDA product code for Ballancer Gold, 1212 is IRP.

其他以 Mego Afek AC , Ltd. 為申請人之記錄

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