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510(k) K010950

CYPRESS SYSTEM by Acuson Corp. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2001
Date Received
March 29, 2001
Clearance Type
Abbreviated
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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  • K021497 — CYPRESS ULTRASOUND SYSTEM (July 9, 2002)
  • K002807 — 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING (December 1, 2000)
  • K992631 — ACUNAV DIAGNOSTIC ULTRASOUND CATHETER (December 15, 1999)
  • K992580 — FETAL ASSESSMENT CAP (October 18, 1999)
  • K991805 — ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION (August 2, 1999)
  • K973767 — HARMONIC IMAGING WITH CONTRAST (December 23, 1997)
  • K973079 — L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM (November 5, 1997)

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