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510(k) K140862

MONICA NOVII WIRELESS PATCH SYSTEM by Monica Healthcare, Ltd. — Product Code OSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2014
Date Received
April 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uterine Electromyographic Monitor
Device Class
Class II
Regulation Number
884.2720
Review Panel
OB
Submission Type

The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.

Other clearances by Monica Healthcare, Ltd.

  • K112390 — MONICA AN24 (July 13, 2012)
  • K112163 — MONICA IF24 (August 30, 2011)
  • K101801 — MONICA AN24 (February 3, 2011)

Other clearances for product code OSP

  • K190798 — LaborView™ LV1000 Wireless Electrode System (September 18, 2020)
  • K153262 — PUREtrace™ (February 7, 2017)
  • K142583 — LaborView LV1000 (January 16, 2015)
  • K131889 — EUM 100PRO (April 23, 2014)
  • K130002 — SURECALL LABOR MONITOR (June 28, 2013)
  • K112390 — MONICA AN24 (July 13, 2012)
  • K112163 — MONICA IF24 (August 30, 2011)
  • K101801 — MONICA AN24 (February 3, 2011)
  • K090145 — SURECALL EMG LABOR MONITOR (January 25, 2011)