K190529 is an FDA 510(k) clearance for the SOZO, 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 November 25, 2019, 266 days after receiving the submission on March 4, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K190529 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 2019 |
| Decision Date | November 25, 2019 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| 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. |