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510(k) K991805

ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION by Acuson Corp. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1999
Date Received
May 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • K973767 — HARMONIC IMAGING WITH CONTRAST (December 23, 1997)
  • K973079 — L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM (November 5, 1997)

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