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

Monitor, Heart-Valve Movement, Fetal, Ultrasonic

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

HEI is the FDA product code for Monitor, Heart-Valve Movement, Fetal, Ultrasonic, a class II device type, regulated under 21 CFR 884.2660. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HEI
Device name
Monitor, Heart-Valve Movement, 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
3
Ingested recalls
0

Clearances, product code HEI

By decision year
3 clearances under product code HEI with a decision year between 1991 and 2002, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HEI by decision year
YearClearances
19911
19921
20021

Applicants with the most clearances

Product code HEI
Applicants holding the most 510(k) clearances under product code HEI
ApplicantClearances
Doctor'S Research Group, Inc.1
M.D. Engineering, Inc.1
Snowden-Pencer1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HEI.