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510(k) K010920

TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING by Medical Cables, Inc. — Product Code HEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2001
Date Received
March 27, 2001
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 Medical Cables, Inc.

  • K002781 — MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE (November 29, 2000)
  • K973970 — SPO2 FINGER PROBES (October 6, 1998)

Other clearances for product code HEL

  • K003876 — US SENSOR #CG-930P; TOCO SENSOR CG-940P (July 9, 2001)
  • K982651 — COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER (December 11, 1998)
  • K971240 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 (June 6, 1997)
  • K930714 — SONICAID MODEL TEAM FECG IUP (August 24, 1995)
  • K933816 — SONICAID MODEL P110 FETAL HEAR DETECTOR (December 22, 1994)
  • K780035 — MINIVISOR (March 6, 1978)