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510(k) K102390

SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM by Sonosite,Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2010
Date Received
August 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
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)
  • K043559 — SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (January 12, 2005)

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