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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 Echo, Ultrasonic
510(k) Number K003725
Device Name 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS
Applicant
Pie Medical
7992 Castleway Dr.
Indianpolis,  IN  46250
Applicant Contact COLLEEN J HITTLE
Correspondent
Pie Medical
7992 Castleway Dr.
Indianpolis,  IN  46250
Correspondent Contact COLLEEN J HITTLE
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received12/04/2000
Decision Date 03/01/2001
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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