VERA— 510(k) K192474

Substantially Equivalent

Reflexion Health, Inc.

FDA 510(k) clearance K192474 for VERA, Substantially Equivalent on 2019-10-10. Applicant: Reflexion Health, Inc.. Device class: 2.

Clearance details

Applicant: Reflexion Health, Inc.
Product code: Code LXJ
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 2019-09-10
Decision date: 2019-10-10
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LXJ

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K172882 — UINCARE HOME2018-05-10

More clearances from Reflexion Health, Inc.

K150462 — Vera2015-10-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.