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510(k) K002807

3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING by Acuson Corp. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2000
Date Received
September 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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