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510(k) K992811

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING by Epic Medical Equipment Services, Inc. — Product Code HFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2000
Date Received
August 20, 1999
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Uterine Contraction, External (For Use In Clinic)
Device Class
Class II
Regulation Number
884.2720
Review Panel
OB
Submission Type

Other clearances by Epic Medical Equipment Services, Inc.

  • K012333 — FLEXI-SITE SP02 EAR SENSOR (October 17, 2001)
  • K002848 — SPO2 WRAP SENSOR (May 24, 2001)
  • K010718 — FLEXI-SITE SP02 EAR SENSOR (March 23, 2001)
  • K002223 — EPIC SPO2 FINGER SENSOR, MODEL E412-20 (August 22, 2000)
  • K000831 — STAT-SHELL DISPOSABLE SP02 SENSOR (June 5, 2000)
  • K992211 — SPO2 WRAP SENSOR (December 22, 1999)
  • K992092 — STAT-SHELL DISPOSABLE SPO2 SENSOR (December 22, 1999)
  • K990082 — EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E (April 9, 1999)
  • K970098 — E100 SERIES SPO2 SENSORS (April 30, 1998)
  • K965172 — OXIMETER PRE-AMP CABLE (July 16, 1997)

Other clearances for product code HFM

  • K140163 — KOALA TOCO (May 29, 2014)
  • K061044 — FEATHERLITE AQUA TOCODYNAMOMETER (July 12, 2006)
  • K040392 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (September 14, 2004)
  • K013477 — TOCO LITE, MODEL TD-01 (January 17, 2002)
  • K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (March 22, 2000)
  • K954847 — DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES (May 22, 1996)
  • K952579 — TOCO TRANSDUCER (August 4, 1995)
  • K920152 — BUBBLE TOCO (May 26, 1993)
  • K910282 — MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER (March 29, 1991)
  • K904691 — AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST (February 19, 1991)