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510(k) K040392

TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING by American I.V. Products, Inc. — Product Code HFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2004
Date Received
February 17, 2004
Clearance Type
Traditional
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 American I.V. Products, Inc.

  • K120209 — PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE (April 12, 2012)
  • K070232 — ECG CABLES, TRUNK AND PATIENT LEAD WIRES (March 27, 2007)
  • K070342 — CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413 (March 19, 2007)
  • K052544 — PULSE OXIMETER ADAPTER CABLES (September 29, 2006)
  • K040819 — TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 (August 16, 2004)
  • K032789 — REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DO (October 9, 2003)

Other clearances for product code HFM

  • K140163 — KOALA TOCO (May 29, 2014)
  • K061044 — FEATHERLITE AQUA TOCODYNAMOMETER (July 12, 2006)
  • K013477 — TOCO LITE, MODEL TD-01 (January 17, 2002)
  • K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (March 22, 2000)
  • K992811 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (January 18, 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)