510(k) K100989
K100989 is an FDA 510(k) premarket notification submitted by Imacor, Inc. for the device "ZURA TEE SYSTEM WITH CLARITEE PROBE". The FDA issued a decision of Substantially Equivalent on June 25, 2010. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Imacor, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2010
- Date Received
- April 9, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type