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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 K870653
Device Name ULTRASOUND LINEAR/SECTOR SCANNER 1100
Applicant
PIE DATA MEDICAL BV
PHILIPSWEG 1
MAASTRICHT 6227 AJ,  NL
Applicant Contact PETER RIKERS
Correspondent
PIE DATA MEDICAL BV
PHILIPSWEG 1
MAASTRICHT 6227 AJ,  NL
Correspondent Contact PETER RIKERS
Regulation Number884.2660
Classification Product Code
KNG  
Date Received02/17/1987
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
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