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510(k) K014116

HAND-CARRIED ULTRASOUND SYSTEM by Sonosite,Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2001
Date Received
December 14, 2001
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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  • 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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