FDA 510(k)

SpeqT

K-Number: K160420 · 2016-03-21

Decision Date2016-03-21

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SpeqT is a medical device manufactured by Signostics Limited. It received FDA 510(k) clearance on 2016-03-21 under approval number K160420. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpeqT?

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

When was SpeqT approved by the FDA?

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

What company makes SpeqT?

SpeqT is manufactured by Signostics Limited.

What is the FDA product code for SpeqT?

The FDA product code for SpeqT is IYO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.