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510(k) K131889

EUM 100PRO by Promedic, Inc. — Product Code OSP

K131889 is an FDA 510(k) premarket notification submitted by Promedic, Inc. for the device "EUM 100PRO". The FDA issued a decision of Substantially Equivalent on April 23, 2014. The device falls under product code OSP (Uterine Electromyographic Monitor), a Class II device regulated under 21 CFR 884.2720. Promedic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2014
Date Received
June 25, 2013
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 Promedic, Inc.

  • K112318 — CLEARPATH 24 (June 29, 2012)
  • K072756 — NON-IV ADAPTER FOR INFANT NG TUBE (December 19, 2007)
  • K060497 — BABYAIR (July 11, 2006)
  • K060842 — REVJET TURBO (June 21, 2006)
  • K052903 — PEDIATRIC FEEDING TUBE (November 9, 2005)
  • K031409 — URINARY CATHETERS (June 17, 2003)
  • K024190 — FENESTRATED INFUSION CATHETER (March 17, 2003)
  • K023579 — GAS SAMPLING LINES (January 28, 2003)
  • K020005 — INFANT FEEDING TUBES (July 16, 2002)
  • K970102 — FILTER (June 24, 1997)

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)
  • K140862 — MONICA NOVII WIRELESS PATCH SYSTEM (August 27, 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)

FDA data resources