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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 K061091
Device Name BABYBEAT CORDLESS
Applicant
THE NEWMAN GROUP, LLC
935 WEST CHESTNUT ST.
SUITE 430
CHICAGO,  IL  60622
Applicant Contact SPENCER NEWMAN
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number884.2660
Classification Product Code
KNG  
Subsequent Product Code
ITX  
Date Received04/19/2006
Decision Date 05/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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