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510(k) K071134

SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM by Sonosite,Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2007
Date Received
April 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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  • K093510 — LUMENVU CATHETER GUIDANCE SYSTEM (August 23, 2010)
  • K101757 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYST (August 12, 2010)
  • K092058 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (October 2, 2009)
  • K082098 — SONOSITE MAXX SERIES ULTRASOUND SYSTEM (August 25, 2008)
  • K053069 — SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (November 16, 2005)
  • K052109 — SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) (August 11, 2005)
  • K043559 — SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (January 12, 2005)

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