Spinalytics— 510(k) K192629

Name: FDA 510(k) clearance K192629
Creator: U.S. Food and Drug Administration
Published: 2019-12-21

Substantially Equivalent

Optima Health Solutions International Corp.

FDA 510(k) clearance K192629 for Spinalytics, Substantially Equivalent on 2019-12-21. Applicant: Optima Health Solutions International Corp.. Device class: Unclassified.

Clearance details

Applicant: Optima Health Solutions International Corp.
Product code: Code LXM
Device class: Unclassified
Advisory panel: Unknown
Date received: 2019-09-23
Decision date: 2019-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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