HEL · Class II · 21 CFR 884.2660

FDA Product Code HEL: Monitor, Heart Rate, Fetal, Ultrasonic

Leading manufacturers include Card Guard Scientific Survival , Ltd., Medical Cables, Inc. and Alexander Mfg. Co..

7
Total
7
Cleared
282d
Avg days
1978
Since

FDA 510(k) Cleared Monitor, Heart Rate, Fetal, Ultrasonic Devices (Product Code HEL)

7 devices
1–7 of 7
Cleared Jul 09, 2001
US SENSOR #CG-930P
K003876
Card Guard Scientific Survival , Ltd.
Obstetrics & Gynecology · 206d
Cleared Jun 22, 2001
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K010920
Medical Cables, Inc.
Obstetrics & Gynecology · 87d
Cleared Dec 11, 1998
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
K982651
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 134d
Cleared Jun 06, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
K971240
Alexander Mfg. Co.
Obstetrics & Gynecology · 65d

About Product Code HEL - Regulatory Context