510(k) K183525 ยท PSV Ultrasound Bronchoscope
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Sep 6, 2019 |
| Received | Dec 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2023 | Aizu Olympus Co., Ltd. Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging,
ultrasound guided needle aspiration and other endoscopic procedures within the
airways, trancheobronchial tree, esophagus and surrou Open, Classified |
PSV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.