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510(k) K003515

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 by Shimadzu Medical Systems — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2001
Date Received
November 14, 2000
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

Other clearances by Shimadzu Medical Systems

  • K082224 — DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC (December 15, 2008)
  • K071291 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (January 9, 2008)
  • K071287 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO (January 9, 2008)
  • K071289 — ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (January 9, 2008)
  • K061643 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (July 27, 2006)
  • K061637 — ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO (July 25, 2006)
  • K061641 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO (July 14, 2006)
  • K052500 — DAR-8000F (October 17, 2005)
  • K052076 — DAR-8000I (September 2, 2005)
  • K050510 — ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 (April 1, 2005)

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