510(k) K143031 ยท KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
mcompass Biofeedback Anorectal Manometry System
| Applicant | Medspira, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 7, 2015 |
| Received | Oct 21, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2017 | Medspira, Llc mcompass 2-channel Balloon Catheters
The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-00 Terminated |
GBT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.