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510(k) K142288

MAC 800 Resting ECG Analysis System by Ge Medical Systems China Co., Ltd. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2014
Date Received
August 18, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

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

  • K151063 — Monitor B40 (December 15, 2015)
  • 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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  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)