510(k) K102801 ยท FFX System, Gastrointestinal Motility (Electrical)
PHTIP DISPOSABLE ISFET CATHETER
| Applicant | E-Cath Co., Ltd., Golden CO, US |
| Decision | Substantially Equivalent, Oct 26, 2010 |
| Received | Sep 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102801
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.