K190208 is an FDA 510(k) clearance for the Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe. This device is classified as a System, Gastrointestinal Motility (electrical) (Class II - Special Controls, product code FFX).
Submitted by Diversatek Healthcare (Highlands Ranch, US). The FDA issued a Cleared decision on October 3, 2019, 241 days after receiving the submission on February 4, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K190208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2019 |
| Decision Date | October 03, 2019 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFX - System, Gastrointestinal Motility (electrical) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1725 |