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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K852704
Device Name TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT
Applicant
CLINCAL INSTRUMENTS CORP.
1717 SUPERIOR AVE.
CLEVELAND,  OH  44114
Applicant Contact LEWIS I SCHWARTZ
Correspondent
CLINCAL INSTRUMENTS CORP.
1717 SUPERIOR AVE.
CLEVELAND,  OH  44114
Correspondent Contact LEWIS I SCHWARTZ
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/26/1985
Decision Date 11/26/1985
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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