FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM

K Number: K013091 · Decision Jan 25, 2002
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
26
Applicant Total
5
Review Days
130

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Basic Information

Device Name
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
K Number
K013091
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.4370
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Von Zeppelin GmbH
Date Received
September 17, 2001
Decision Date
January 25, 2002
Product Code
HBB
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HBB Motor, Drill, Pneumatic

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K901313 INSTRUMENTS FOR NEUROLOGICAL SURGERY