CARDIOCAP CMX-104 MONITOR

System, Measurement, Blood-pressure, Non-invasive

DATEX DIVISION INSTRUMENTARIUM CORP.

The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Cardiocap Cmx-104 Monitor.

Pre-market Notification Details

Device IDK903237
510k NumberK903237
Device Name:CARDIOCAP CMX-104 MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland,  FI
ContactHannu Ahjopalo
CorrespondentHannu Ahjopalo
DATEX DIVISION INSTRUMENTARIUM CORP. P.O. BOX 446 SF-00101 Helsinki, Finland,  FI
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-23
Decision Date1991-07-17

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