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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K000443
Device Name REMOTE FETAL MEDICINE ULTRASOUND SYSTEM
Applicant
R4 TELEMEDICINE, INC.
1301 K ST. N.W.
SUITE 800 EAST
WASHINGTON,  DC  20005 -3333
Applicant Contact THOMAS B SMITH
Correspondent
R4 TELEMEDICINE, INC.
1301 K ST. N.W.
SUITE 800 EAST
WASHINGTON,  DC  20005 -3333
Correspondent Contact THOMAS B SMITH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/10/2000
Decision Date 04/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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