TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT

System, Monitoring, Perinatal

CLINCAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Tweetheart #102 Fetal/neonatal Heartbeat Annunciat.

Pre-market Notification Details

Device IDK852704
510k NumberK852704
Device Name:TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT
ClassificationSystem, Monitoring, Perinatal
Applicant CLINCAL INSTRUMENTS CORP. 1717 SUPERIOR AVE. Cleveland,  OH  44114
ContactLewis I Schwartz
CorrespondentLewis I Schwartz
CLINCAL INSTRUMENTS CORP. 1717 SUPERIOR AVE. Cleveland,  OH  44114
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-26
Decision Date1985-11-26

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