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510(k) K930964

ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) by Acuson Corp. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1994
Date Received
February 24, 1993
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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  • K991805 — ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION (August 2, 1999)
  • K973767 — HARMONIC IMAGING WITH CONTRAST (December 23, 1997)

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