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510(k) Data Aggregation
K Number
K964933Device Name
MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)Manufacturer
Date Cleared
1997-02-03
(55 days)
Product Code
Regulation Number
888.1240Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
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Applicant Name (Manufacturer) :
MEKANIKA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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