Adjunct Monitor, Protein Calorie Malnutrition

QJB · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2770

Classification

FDA Product Code: QJB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.2770
Review panel: GU
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown