510(k) K080223 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ZURA TEE SYSTEM
| Applicant | Imacor, LLC, Philadelphia PA, US |
| Decision | Substantially Equivalent, Jun 24, 2008 |
| Received | Jan 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080223
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2024 | ImaCor Inc. ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms.
Model/Catalog Number: CLT-010, CLT-010-1 Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.