DARI Health
K-Number: K180880 · 2019-03-07
ApplicantScientific Analytics, Inc.
Decision Date2019-03-07
Product CodeLXJ
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
DARI Health is a medical device manufactured by Scientific Analytics, Inc.. It received FDA 510(k) clearance on 2019-03-07 under approval number K180880. 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 DARI Health?
DARI Health is a medical device that received FDA 510(k) clearance on 2019-03-07. It is manufactured by Scientific Analytics, Inc.. The 510(k) number is K180880.
When was DARI Health approved by the FDA?
DARI Health received FDA 510(k) clearance on 2019-03-07, under approval number K180880.
What company makes DARI Health?
DARI Health is manufactured by Scientific Analytics, Inc..
What is the FDA product code for DARI Health?
The FDA product code for DARI Health is LXJ.
Related Devices (Code: LXJ)
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.