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K Number
K002704

Validate with FDA (Live)

Device Name
KSEA MINIATURE NEUROENDOSCOPE
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2000-11-03

(65 days)

Product Code
GWG
Regulation Number
882.1480
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K014149
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).