510(k) K100989 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ZURA TEE SYSTEM WITH CLARITEE PROBE
| Applicant | Imacor, Inc., Uniondale NY, US |
| Decision | Substantially Equivalent, Jun 25, 2010 |
| Received | Apr 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100989
| 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.