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

Monitor, Blood-Flow, Ultrasonic

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

HEP is the FDA product code for Monitor, Blood-Flow, Ultrasonic, a class II device type, regulated under 21 CFR 884.2660. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HEP
Device name
Monitor, Blood-Flow, 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
4
Ingested recalls
0

Clearances, product code HEP

By decision year
4 clearances under product code HEP with a decision year between 1991 and 2010, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HEP by decision year
YearClearances
19911
19921
20031
20101

Applicants with the most clearances

Product code HEP
Applicants holding the most 510(k) clearances under product code HEP
ApplicantClearances
Bionet Co., Ltd.1
Edan Instruments, Inc.1
Imex Medical Systems, Inc.1
Ultracell Medical Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code