HEL · Class II · 21 CFR 884.2660

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

Leading manufacturers include Card Guard Scientific Survival , Ltd. 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 06, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
K971240
Alexander Mfg. Co.
Obstetrics & Gynecology · 65d

About Product Code HEL - Regulatory Context