ZURA TEE SYSTEM WITH CLARITEE PROBE
FDA 510(k) clearance K100989 · decided 2010-06-25
Clearance details
- K-number
- K100989
- Device name
- ZURA TEE SYSTEM WITH CLARITEE PROBE
- Applicant
- Imacor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-09
- Decision date
- 2010-06-25
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Uniondale, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Imacor
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultras recall (Z-0231-2025) | ImaCor Inc. | 2024-10-25 |