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510(k) K052076

DAR-8000I by Shimadzu Medical Systems — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2005
Date Received
August 1, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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  • 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)
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  • K003515 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 (February 12, 2001)

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