510(k) K190208 ยท FFX System, Gastrointestinal Motility (Electrical)
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
| Applicant | Diversatek Healthcare, Highlands Ranch CO, US |
| Decision | Substantially Equivalent, Oct 3, 2019 |
| Received | Feb 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2025 | Diversatek Healthcare Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 Open, Classified |
FFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.