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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K120234
Device Name EZONO 3000
Original Applicant
LIFE-TECH, INC.
13235 n promenade blvd
stafford,  TX  77477
Original Contact skip rimer
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/25/2012
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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