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HEL — Monitor, Heart Rate, Fetal, Ultrasonic Class II

FDA Device Classification

Classification Details

Product Code
HEL
Device Class
Class II
Regulation Number
884.2660
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K003876card guard scientific survivalUS SENSOR #CG-930P; TOCO SENSOR CG-940PJuly 9, 2001
K010920medical cablesTRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGJune 22, 2001
K982651corometrics medical systemsCOROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERDecember 11, 1998
K971240alexander mfgALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006June 6, 1997
K930714oxford instrumentsSONICAID MODEL TEAM FECG IUPAugust 24, 1995
K933816oxford instrumentsSONICAID MODEL P110 FETAL HEAR DETECTORDecember 22, 1994
K780035metrix teknikaMINIVISORMarch 6, 1978