QJB — Adjunct Monitor, Protein Calorie Malnutrition Class II
FDA product code QJB covers "Adjunct Monitor, Protein Calorie Malnutrition", a Class II medical device regulated under 21 CFR 870.2770. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QJB
- Device Class
- Class II
- Regulation Number
- 870.2770
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Cardiovascular
- Implant
- No
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.