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510(k) K930714

SONICAID MODEL TEAM FECG IUP by Oxford Instruments, Plc. — Product Code HEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1995
Date Received
February 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Heart Rate, Fetal, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

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  • K961642 — MEDILOG MR95 (January 17, 1997)
  • K961636 — MEDILOG VISION (January 17, 1997)
  • K933816 — SONICAID MODEL P110 FETAL HEAR DETECTOR (December 22, 1994)

Other clearances for product code HEL

  • K003876 — US SENSOR #CG-930P; TOCO SENSOR CG-940P (July 9, 2001)
  • K010920 — TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING (June 22, 2001)
  • K982651 — COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER (December 11, 1998)
  • K971240 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 (June 6, 1997)
  • K933816 — SONICAID MODEL P110 FETAL HEAR DETECTOR (December 22, 1994)
  • K780035 — MINIVISOR (March 6, 1978)