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

Monitor, Cardiac, Fetal

21 CFR 884.2600 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

KXN is the FDA product code for Monitor, Cardiac, Fetal, a class II device type, regulated under 21 CFR 884.2600. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KXN
Device name
Monitor, Cardiac, Fetal
Regulation
21 CFR 884.2600
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
2
Ingested recalls
1

Clearances, product code KXN

By decision year
2 clearances under product code KXN with a decision year between 1976 and 1977, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KXN by decision year
YearClearances
19761
19771

Applicants with the most clearances

Product code KXN
Applicants holding the most 510(k) clearances under product code KXN
ApplicantClearances
Hewlett-Packard Co.1
Mennen Greatbatch Electonics1

Companies listing this code with FDA

Companies whose registered establishments list this code

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