510(k) K190529
K190529 is an FDA 510(k) premarket notification submitted by ImpediMed Limited for the device "SOZO". The FDA issued a decision of Substantially Equivalent on November 25, 2019. The device falls under product code QJB (Adjunct Monitor, Protein Calorie Malnutrition), a Class II device regulated under 21 CFR 870.2770. ImpediMed Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2019
- Date Received
- March 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunct Monitor, Protein Calorie Malnutrition
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- GU
- Submission Type
Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.