510(k) K021278 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
| Applicant | Pentax Precision Instrument Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Sep 6, 2002 |
| Received | Apr 22, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021278
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.