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510(k) K061044

FEATHERLITE AQUA TOCODYNAMOMETER by Ventrex, Inc. — Product Code HFM

K061044 is an FDA 510(k) premarket notification submitted by Ventrex, Inc. for the device "FEATHERLITE AQUA TOCODYNAMOMETER". The FDA issued a decision of Substantially Equivalent on July 12, 2006. 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
July 12, 2006
Date Received
April 14, 2006
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.

  • K013477 — TOCO LITE, MODEL TD-01 (January 17, 2002)
  • 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)
  • 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)
  • 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