Device Classification Name |
transducer, ultrasonic, diagnostic
|
510(k) Number |
K092756 |
Device Name |
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM |
Applicant |
GE VINGMED ULTRASOUND AS |
STRANDPROMENADEN 45 |
HORTEN,
NO
N-3183
|
|
Applicant Contact |
JAN T THOLLEFSEN |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1570
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/09/2009 |
Decision Date | 09/28/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|