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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K870058
Device Name PIE MEDICAL SCANNER 1000
Applicant
Pie Data Medical BV
Philipsweg 1
Maastricht 6227 Aj,  NL
Applicant Contact RIKERS
Correspondent
Pie Data Medical BV
Philipsweg 1
Maastricht 6227 Aj,  NL
Correspondent Contact RIKERS
Regulation Number884.2660
Classification Product Code
KNG  
Date Received01/07/1987
Decision Date 02/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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