510(k) K013640 ยท FDS Gastroscope And Accessories, Flexible/Rigid
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
| Applicant | Pentax Precision Instrument Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Feb 4, 2002 |
| Received | Nov 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013640
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.