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510(k) Data Aggregation
K Number
K021098Device Name
DAUM-LECTRIC MRI DRILLING MACHINE
Manufacturer
Date Cleared
2002-12-03
(243 days)
Product Code
Regulation Number
874.4250Why did this record match?
Applicant Name (Manufacturer) :
MRI DEVICES DAUM GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Daum p-lectric Drilling Machine is a piezoelectrically driven hand held drill intended to assist the surgeon to access bony tissue. The Daum p-lectric Drilling Machine can drill into hard and soft bone tissue to create a small hole or to obtain bony tissue samples. The Daum p-lectric Drilling Machine is designed to be used inside or close to an MRI Unit up to 1.5 Tesla.
Device Description
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