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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 K880580
Device Name EXTENDED MULTIPURPOSE TRANSDUCER RANGE
Applicant
Pie Medical USA BV
3535 Rte. 66 Pkwy. 100
Neptune Township,  NJ  07753
Applicant Contact RIKER
Correspondent
Pie Medical USA BV
3535 Rte. 66 Pkwy. 100
Neptune Township,  NJ  07753
Correspondent Contact RIKER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received02/10/1988
Decision Date 06/08/1988
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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