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510(k) Data Aggregation
K Number
K230996Device Name
Pursuant Health Kiosk (G1.D5)
Manufacturer
Date Cleared
2024-01-04
(272 days)
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Pursuant Health
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pursuant Health Kiosk is intended to be used by the general public so that a user can measure their own blood pressure, pulse rate, and weight. Additionally, the kiosk can capture digital images of an adult user's retina without the use of a mydriatic agent. It is not a diagnostic device and only furnishes retinal images that users can send to their personal physician or other healthcare professional.
Device Description
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