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510(k) K874631

HEALTHPHONE TOCO MODEL by Carelink — Product Code HFM

K874631 is an FDA 510(k) premarket notification submitted by Carelink for the device "HEALTHPHONE TOCO MODEL". The FDA issued a decision of Substantially Equivalent on March 11, 1988. 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. Carelink has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1988
Date Received
November 10, 1987
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 Carelink

  • K862668 — HEALTHPHONE(TM) (December 22, 1986)

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