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FDA 510(k)

QyScore Software

K-Number: K192531 · 2019-12-13

ApplicantQynapse
Decision Date2019-12-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QyScore Software is a medical device manufactured by Qynapse. It received FDA 510(k) clearance on 2019-12-13 under approval number K192531. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QyScore Software?

QyScore Software is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Qynapse. The 510(k) number is K192531.

When was QyScore Software approved by the FDA?

QyScore Software received FDA 510(k) clearance on 2019-12-13, under approval number K192531.

What company makes QyScore Software?

QyScore Software is manufactured by Qynapse.

What is the FDA product code for QyScore Software?

The FDA product code for QyScore Software is LLZ.

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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.

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