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510(k) Data Aggregation
K Number
K020400Device Name
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
Manufacturer
MEPS, LLC.
Date Cleared
2002-08-23
(198 days)
Product Code
GWF
Regulation Number
882.1870Why did this record match?
Applicant Name (Manufacturer) :
MEPS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digitimer D185 is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
Device Description
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