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510(k) K030064

ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY by Sonosite,Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2003
Date Received
January 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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  • K092058 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (October 2, 2009)
  • K082098 — SONOSITE MAXX SERIES ULTRASOUND SYSTEM (August 25, 2008)
  • K071134 — SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM (May 8, 2007)
  • K053069 — SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (November 16, 2005)
  • K052109 — SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) (August 11, 2005)

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