Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
|
Device | ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM |
Generic Name | System, imaging, pulsed doppler, ultrasonic |
Regulation Number | 892.1550 |
Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 BOTHELL, WA 98041-3003 |
PMA Number | P940005 |
Date Received | 02/17/1994 |
Decision Date | 04/11/1996 |
Withdrawal Date
|
05/04/2009 |
Product Code |
IYN |
Docket Number | 96M-0450 |
Notice Date | 11/29/1996 |
Advisory Committee |
Radiology |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ULTRAMARK 9 HIGH DEFINITION IMAGING (HDI) ULTRASOUND SYSTEM WITH L10-5 SCANHEAD |
Supplements: |
S001 S002 |
|
|