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510(k) K930714

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

K930714 is an FDA 510(k) premarket notification submitted by Oxford Instruments, Plc. for the device "SONICAID MODEL TEAM FECG IUP". The FDA issued a decision of Substantially Equivalent on August 24, 1995. The device falls under product code HEL (Monitor, Heart Rate, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Oxford Instruments, Plc. has at least 6 other 510(k) clearances on record.

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

Other clearances by Oxford Instruments, Plc.

  • K002150 — SONICAID FM820, SONICAID FM830 (March 9, 2001)
  • K002544 — MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM (September 13, 2000)
  • K981405 — SYNERGY LT (July 16, 1998)
  • 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)

FDA data resources