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FDA 510(k)

設備名稱醫療設備規範文本 SpeqT

K 號：K160420 · 2016-03-21

申請人Signostics Limited
決定日期2016-03-21
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

SpeqT is the device name listed in this FDA 510(k) record. The listed applicant is Signostics Limited. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K160420. 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 SpeqT?

SpeqT is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is Signostics Limited. The 510(k) number is K160420.

When did SpeqT receive FDA 510(k) clearance?

SpeqT received FDA 510(k) clearance on 2016-03-21, under 510(k) number K160420.

Who is the listed applicant for SpeqT?

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

What is the FDA product code for SpeqT?

The FDA product code for SpeqT is IYO.

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官方來源

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