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FDA 510(k)

VERA

K-Number: K192474 · 2019-10-10

ApplicantReflexion Health, Inc.
Decision Date2019-10-10
Product CodeLXJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VERA is a medical device manufactured by Reflexion Health, Inc.. It received FDA 510(k) clearance on 2019-10-10 under approval number K192474. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERA?

VERA is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Reflexion Health, Inc.. The 510(k) number is K192474.

When was VERA approved by the FDA?

VERA received FDA 510(k) clearance on 2019-10-10, under approval number K192474.

What company makes VERA?

VERA is manufactured by Reflexion Health, Inc..

What is the FDA product code for VERA?

The FDA product code for VERA is LXJ.

Other Devices by Reflexion Health, Inc.

K182333Vera

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Official Source

View on FDA Database →

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

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