K230531 is an FDA 510(k) clearance for the SOZO Pro. This device is classified as a Adjunct Monitor, Protein Calorie Malnutrition (Class II - Special Controls, product code QJB).
Submitted by ImpediMed Limited (Pinkenba, AU). The FDA issued a Cleared decision on May 4, 2023, 66 days after receiving the submission on February 27, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770. 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) Number | K230531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2023 |
| Decision Date | May 04, 2023 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QJB - Adjunct Monitor, Protein Calorie Malnutrition |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |
| 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. |