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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 K900469
Device Name ULTRASOUND SCANNER MODEL #1150
Applicant
Pie Medical USA BV
3535 Rte. 66 Pkwy. 100
Neptune Township,  NJ  07753
Applicant Contact PETER RIKERS
Correspondent
Pie Medical USA BV
3535 Rte. 66 Pkwy. 100
Neptune Township,  NJ  07753
Correspondent Contact PETER RIKERS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/31/1990
Decision Date 07/09/1990
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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