K203473 is an FDA 510(k) clearance for the SOZO. 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 April 19, 2021, 145 days after receiving the submission on November 25, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K203473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2020 |
| Decision Date | April 19, 2021 |
| Days to Decision | 145 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 |