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510(k) K920152

BUBBLE TOCO by Utah Medical Products, Inc. — Product Code HFM

K920152 is an FDA 510(k) premarket notification submitted by Utah Medical Products, Inc. for the device "BUBBLE TOCO". The FDA issued a decision of Substantially Equivalent on May 26, 1993. 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. Utah Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1993
Date Received
January 13, 1992
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 Utah Medical Products, Inc.

  • K143424 — UTAH CVX-RIPE (August 28, 2015)
  • K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) (January 23, 2013)
  • K101535 — BT-CATH (January 11, 2011)
  • K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER (May 23, 2007)
  • K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER (September 25, 2000)
  • K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX (May 23, 2000)
  • K965245 — TBD (July 3, 1997)
  • K970077 — LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (May 23, 1997)
  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER (February 10, 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)
  • 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)
  • K910282 — MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER (March 29, 1991)
  • K904691 — AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST (February 19, 1991)

FDA data resources