Adjunct Monitor, Protein Calorie Malnutrition
The Adjunct Monitor for Protein Calorie Malnutrition is a Class 2 device that applies an alternating current of one or more specified frequencies through skin-surface electrodes to estimate body composition parameters, used as an adjunct in assessing nutritional status. It requires 510(k) clearance and is regulated under 21 CFR 870.2770, reviewed by the Gastroenterology and Urology panel under the Cardiovascular medical specialty classification. The product code is QJB. The device is not an implant and is not flagged as life-sustaining.
Research product code QJB in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QJB
- Device Class
- FDA class 2
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.