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

Monitor, Heart Rate, Fetal, Ultrasonic

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

HEL is the FDA product code for Monitor, Heart Rate, Fetal, Ultrasonic, a class II device type, regulated under 21 CFR 884.2660. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HEL
Device name
Monitor, Heart Rate, 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
7
Ingested recalls
0

Clearances, product code HEL

By decision year
7 clearances under product code HEL with a decision year between 1978 and 2001, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HEL by decision year
YearClearances
19781
19941
19951
19971
19981
20012

Applicants with the most clearances

Product code HEL
Applicants holding the most 510(k) clearances under product code HEL
ApplicantClearances
Oxford Instruments, PLC.2
Alexander Mfg. Co.1
Card Guard Scientific Survival, Ltd.1
Corometrics Medical Systems, Inc.1
Medical Cables, Inc.1
Metrix Teknika, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code