510(k) K213235 ยท EOQ Bronchoscope (Flexible Or Rigid)
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Dec 21, 2022 |
| Received | Sep 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213235
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.