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510(k) K160343

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner by Beijing East Whale Imaging Technology Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2016
Date Received
February 8, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Beijing East Whale Imaging Technology Co., Ltd.

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  • K141672 — DIGIARC 100AU+ (July 31, 2014)
  • K131423 — G-ARM MULTISCAN SYSTEM (November 7, 2013)

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