Product code HEK— Obstetrics/Gynecology

BIODOP(TM)

Classification name: Monitor, Heart Sound, Fetal, Ultrasonic
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Total cleared: 5
First cleared: 1977-07-14
Most recent: 2015-03-20

Market context for product code HEK

FDA has cleared 5 devices under product code HEK between 1977 and 2015, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20151 clearance
20061 clearance
19901 clearance
19881 clearance
19771 clearance

Top applicants under product code HEK

Terumo America, Inc.1 clearance
Summit Doppler Systems, Inc.1 clearance
Icare Newlife Technologies, Inc.1 clearance
Diagnosis Related Systems, Inc.1 clearance
Advanced Medical Systems, Inc.1 clearance

Recent clearances under product code HEK

K142769 — Fetal DopplerIcare Newlife Technologies, Inc.·2015-03-20
K060410 — ECHOHEART TRANSVAGINAL DOPPLER PROBESummit Doppler Systems, Inc.·2006-04-10
K902190 — FETAL PULSE DETECTOR MODEL DOP-1Advanced Medical Systems, Inc.·1990-10-22
K883334 — BIODOP(TM)Diagnosis Related Systems, Inc.·1988-12-15
K771211 — DOPPLER (UTD-5 & UTD-6)Terumo America, Inc.·1977-07-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.