Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K100989 |
Device Name |
ZURA TEE SYSTEM WITH CLARITEE PROBE |
Applicant |
IMACOR INC. |
50 CHARLES LINDBERGH BLVD |
SUITE 200 |
UNIONDALE,
NY
11553
|
|
Applicant Contact |
RICHARD LANZILLOTTO |
Correspondent |
IMACOR INC. |
50 CHARLES LINDBERGH BLVD |
SUITE 200 |
UNIONDALE,
NY
11553
|
|
Correspondent Contact |
RICHARD LANZILLOTTO |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/09/2010 |
Decision Date | 06/25/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|