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510(k) K860933

AIR-CUSHION TOCOTONOMETER by International Biomedics, Inc. — Product Code HFM

K860933 is an FDA 510(k) premarket notification submitted by International Biomedics, Inc. for the device "AIR-CUSHION TOCOTONOMETER". The FDA issued a decision of Substantially Equivalent on July 9, 1986. 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. International Biomedics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1986
Date Received
March 12, 1986
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 International Biomedics, Inc.

  • K031096 — MODIFICATION TO TRANSPORT INCUBATOR 185 (June 24, 2003)
  • K862072 — FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 (July 9, 1986)
  • K860295 — FETASCAN 1500 (May 19, 1986)
  • K852439 — FETA SCAN 1000 OBSTETRICAL IMAGER (August 30, 1985)

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)
  • K920152 — BUBBLE TOCO (May 26, 1993)
  • K910282 — MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER (March 29, 1991)

FDA data resources