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FDA 510(k)

DARI Health

K-Number: K180880 · 2019-03-07

Decision Date2019-03-07
Product CodeLXJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DARI Health is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Analytics, Inc.. It received FDA 510(k) clearance on 2019-03-07 under 510(k) 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. The listed applicant is Scientific Analytics, Inc.. The 510(k) number is K180880.

When did DARI Health receive FDA 510(k) clearance?

DARI Health received FDA 510(k) clearance on 2019-03-07, under 510(k) number K180880.

Who is the listed applicant for DARI Health?

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

What is the FDA product code for DARI Health?

The FDA product code for DARI Health is LXJ.

Related Devices (Code: LXJ)

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.

Official Source

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