DARI Health— 510(k) K180880

Substantially Equivalent

Scientific Analytics, Inc.

FDA 510(k) clearance K180880 for DARI Health, Substantially Equivalent on 2019-03-07. Applicant: Scientific Analytics, Inc.. Device class: 2.

Clearance details

Applicant: Scientific Analytics, Inc.
Product code: Code LXJ
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 2018-04-03
Decision date: 2019-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln, NE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LXJ

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K172882 — UINCARE HOME2018-05-10

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