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510(k) K091164

GE VENUE 40, MODEL 5324338 by Ge Medical Systems China Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2009
Date Received
April 22, 2009
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

Other clearances by Ge Medical Systems China Co., Ltd.

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  • K142288 — MAC 800 Resting ECG Analysis System (December 3, 2014)
  • K133576 — MONITOR B40 (February 21, 2014)
  • K130584 — MONITOR B40 (June 26, 2013)
  • K122253 — PROCARE MONITOR B20 (March 22, 2013)
  • K123238 — ACHILLES (February 25, 2013)
  • K120598 — PROCARE MONITOR B40 (July 19, 2012)
  • K103633 — ACHILLES (May 11, 2011)
  • K102256 — GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND (October 5, 2010)
  • K102113 — GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND (August 12, 2010)

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