FDA 510(k)

QyScore Software

K-Number: K192531 · 2019-12-13

Decision Date2019-12-13

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QyScore Software is the device name listed in this FDA 510(k) record. The listed applicant is Qynapse. It received FDA 510(k) clearance on 2019-12-13 under 510(k) 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. The listed applicant is Qynapse. The 510(k) number is K192531.

When did QyScore Software receive FDA 510(k) clearance?

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

Who is the listed applicant for QyScore Software?

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

What is the FDA product code for QyScore Software?

The FDA product code for QyScore Software is LLZ.

Related Devices (Code: 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.