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

Adjunct Monitor, Protein Calorie Malnutrition

21 CFR 870.2770 / Cardiovascular
FDA source (opens on fda.gov)

QJB is the FDA product code for Adjunct Monitor, Protein Calorie Malnutrition, a class II device type, regulated under 21 CFR 870.2770. FDA's definition for this code reads: "Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QJB
Device name
Adjunct Monitor, Protein Calorie Malnutrition
FDA definition
Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QJB

By decision year
2 clearances under product code QJB with a decision year between 2019 and 2023, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QJB by decision year
YearClearances
20191
20231

Applicants with the most clearances

Product code QJB
Applicants holding the most 510(k) clearances under product code QJB
ApplicantClearances
Impedimed, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code