K232089 is an FDA 510(k) clearance for the SOZO Pro, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by ImpediMed Limited (Pinkenba, AU). The FDA issued a Cleared decision on October 17, 2023, 96 days after receiving the submission on July 13, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K232089 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 2023 |
| Decision Date | October 17, 2023 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | DSB — Plethysmograph, Impedance |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2770 |