Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K110688 |
Device Name |
MYLABGOLD |
Applicant |
ESAOTE |
11460 N. MERIDIAN ST., |
STE. 150 |
CARMEL,
IN
46032
|
|
Applicant Contact |
Allison Scott |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/11/2011 |
Decision Date | 06/02/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|