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510(k) K151063

Monitor B40 by Ge Medical Systems China Co., Ltd. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2015
Date Received
April 20, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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

  • 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)
  • K091374 — GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND (May 26, 2009)

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