FDA Product Code QJB: Adjunct Monitor, Protein Calorie Malnutrition
Device Applies An Alternating Current Of One Specified Frequency Or More Through Skin-surface Electrodes To Estimate One Or More The Body Composition Parameters.
Leading manufacturers include ImpediMed Limited.
2
Total
2
Cleared
166d
Avg days
2019
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Adjunct Monitor, Protein Calorie Malnutrition Devices (Product Code QJB)
2 devices
About Product Code QJB - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QJB since 2019, with 2 receiving FDA clearance (average review time: 166 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QJB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →