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510(k) K013477

TOCO LITE, MODEL TD-01 by Ventrex, Inc. — Product Code HFM

K013477 is an FDA 510(k) premarket notification submitted by Ventrex, Inc. for the device "TOCO LITE, MODEL TD-01". The FDA issued a decision of Substantially Equivalent on January 17, 2002. The device falls under product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)), a Class II device regulated under 21 CFR 884.2720. Ventrex, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2002
Date Received
October 19, 2001
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 Ventrex, Inc.

  • K061044 — FEATHERLITE AQUA TOCODYNAMOMETER (July 12, 2006)
  • K964821 — COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 (July 16, 1997)
  • K963415 — VENTREX OXYGEN SENSOR (November 25, 1996)
  • K925044 — VENTREX ALLERGEN DISC (May 14, 1993)
  • K924119 — VENTREX ALLERGEN DISC (November 30, 1992)

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)
  • 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)

FDA data resources