510(k) K041397 ยท ITX Transducer, Ultrasonic, Diagnostic
EG-3830UT
| Applicant | Pentax Precision Instrument Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Jun 9, 2004 |
| Received | May 26, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2014 | Pentax Medical Company EG-3630U Ultrasound Video Gastroscope
EG-3830UT Ultrasound Video Gastroscope
EG-3870UTK Ultrasound Video Gastroscope
FG-36UX Ultrasound Fiber Gastroscope
Used to provide optical and sonographic visu Terminated |
FDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.