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510(k) K010721

AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM by Siemens Medical Corp. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2001
Date Received
March 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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