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510(k) K954847

DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES by Ocg Systems, Inc. — Product Code HFM

K954847 is an FDA 510(k) premarket notification submitted by Ocg Systems, Inc. for the device "DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on May 22, 1996. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1996
Date Received
October 23, 1995
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 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)
  • K992811 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (January 18, 2000)
  • 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