510(k) K951199 ยท EOQ Bronchoscope (Flexible Or Rigid)
FB-18X, FIBER BRONCHOSCOPE
| Applicant | Pentax Precision Instrument Corp., Miramar FL, US |
| Decision | Substantially Equivalent, Apr 10, 1995 |
| Received | Mar 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951199
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | Pentax Medical Company Bronchoscope
Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Terminated |
EOQ | None listed |
| Jun 28, 2016 | Pentax Medical Company Ultrasound Bronchoscope
Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and sub Terminated |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.