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K Number
K003612
Device Name
MICROSPEED EC MOTORSYSTEM GD650/GD653
Manufacturer
AESCULAP, INC.
Date Cleared
2001-02-20

(90 days)

Product Code
HBC
Regulation Number
882.4360
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).