510(k) K130706 ยท MOS Coil, Magnetic Resonance, Specialty
DUOFLEX COIL SUITE (1.5T)
| Applicant | Mr Instruments, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 25, 2013 |
| Received | Mar 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130706
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2017 | Pentax of America Inc Ultrasound Video Gastroscope, Model EG-3670URK,
The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical vide Terminated |
ODG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.