FDA 510(k)

Vera

K-Number: K182333 · 2019-04-09

Decision Date2019-04-09

Product CodeLXJ

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Vera is the device name listed in this FDA 510(k) record. The listed applicant is Reflexion Health, Inc.. It received FDA 510(k) clearance on 2019-04-09 under 510(k) number K182333. 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 2019-04-09. The listed applicant is Reflexion Health, Inc.. The 510(k) number is K182333.

When did Vera receive FDA 510(k) clearance?

Vera received FDA 510(k) clearance on 2019-04-09, under 510(k) number K182333.

Who is the listed applicant for Vera?

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

What is the FDA product code for Vera?

The FDA product code for Vera is LXJ.

Other records listing Reflexion Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192474VERA

Related Devices (Code: LXJ)

K192474VERAReflexion Health, Inc.K180880DARI HealthScientific Analytics, Inc.K171547Qualisys Clinical SystemQualisys AB K173931MindMotion(TM) GOMindmaze SA K172882UINCARE HOMEUincare Corp.K162748MindMotionPROMindmaze SA

Official Source

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