K190529 is an FDA 510(k) clearance for the SOZO. 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 November 25, 2019, 266 days after receiving the submission on March 4, 2019.
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 | K190529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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. |