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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 K111934
Device Name PD-100 SERIES ULTRASONIC POCKET DOPPLER
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 WEST 20 ST
HIALEAH,  FL  33010
Applicant Contact JORGE MILLAN
Correspondent
ADVANCED INSTRUMENTATIONS, INC.
601 WEST 20 ST
HIALEAH,  FL  33010
Correspondent Contact JORGE MILLAN
Regulation Number884.2660
Classification Product Code
KNG  
Subsequent Product Code
HEP  
Date Received07/08/2011
Decision Date 09/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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