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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM
Classification Namesystem, imaging, pulsed doppler, ultrasonic
Generic Namesystem, imaging, pulsed doppler, ultrasonic
Regulation Number892.1550
Applicant
ADVANCED TECHNOLOGY LABORATORIES, INC.
22100 bothell everett hwy.
p.o. box 3003
bothell, WA 98041-3003
PMA NumberP940005
Date Received02/17/1994
Decision Date04/11/1996
Withdrawal Date 05/04/2009
Product Code
IYN[ Registered Establishments with 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 
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