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510(k) K994353

SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 by Precision Dynamics Corp. — Product Code HFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2000
Date Received
December 23, 1999
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 Precision Dynamics Corp.

  • K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (June 3, 2002)
  • K994263 — SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 (January 24, 2000)
  • K990737 — 'ECURLINE UMBILICAL CORD CLAMP #3500 (April 6, 1999)
  • K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (November 1, 1988)
  • K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE (July 8, 1988)
  • K874665 — SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY (January 20, 1988)
  • K873369 — SECURLINE FRANSEENE NEEDLE (October 20, 1987)
  • K872507 — PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II (July 9, 1987)
  • K863164 — AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (August 27, 1986)
  • K851364 — FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP (April 22, 1985)

Other clearances for product code HFM

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  • 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)
  • 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)