K232089 is an FDA 510(k) clearance for the SOZO Pro. This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K232089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |