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K Number
K011444

Validate with FDA (Live)

Device Name
ANSPACH EMAX DRILL SYSTEM
Manufacturer
THE ANSPACH EFFORT, INC.
Date Cleared
2001-08-08

(89 days)

Product Code
HBC
Regulation Number
882.4360
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K020688,K022907,K022942,K022986,K030576,K080444,K080802,K131053,K133604
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.4360 Electric cranial drill motor.

(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).