510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HEKClass II

Monitor, Heart Sound, Fetal, Ultrasonic

21 CFR 884.2660 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HEK is the FDA product code for Monitor, Heart Sound, Fetal, Ultrasonic, a class II device type, regulated under 21 CFR 884.2660. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HEK
Device name
Monitor, Heart Sound, Fetal, Ultrasonic
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
0

Clearances, product code HEK

By decision year
5 clearances under product code HEK with a decision year between 1977 and 2015, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HEK by decision year
YearClearances
19771
19881
19901
20061
20151

Applicants with the most clearances

Product code HEK
Applicants holding the most 510(k) clearances under product code HEK
ApplicantClearances
Advanced Medical Systems, Inc.1
Diagnosis Related Systems, Inc.1
Icare Newlife Technologies, Inc.1
Summit Doppler Systems, Inc.1
Terumo America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code