510(k) K131946 ยท EOQ Bronchoscope (Flexible Or Rigid)
ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
| Applicant | Pentax Medical Company, Montvale NJ, US |
| Decision | Substantially Equivalent, Apr 25, 2014 |
| Received | Jun 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131946
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2016 | Pentax of America Inc Ultrasound Video Bronchoscope
The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Trac Terminated |
EOQ | None listed |
| Jan 11, 2011 | Pentax of America Inc Video Bronchoscope Terminated |
EOQ | None listed |
| Jan 11, 2011 | Pentax of America Inc Video Cytoscopes Terminated |
EOQ | None listed |
| Jan 11, 2011 | Pentax of America Inc Video Naso pharyngo Laryngoscopes Terminated |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.