510(k) K953876 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Nov 24, 1995 |
| Received | Aug 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953876
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.