CARDIOCAP II TM CH-RESP MONITORS

Electrocardiograph

INSTRUMENTARIUM CORP.

The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Cardiocap Ii Tm Ch-resp Monitors.

Pre-market Notification Details

Device IDK904355
510k NumberK904355
Device Name:CARDIOCAP II TM CH-RESP MONITORS
ClassificationElectrocardiograph
Applicant INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland,  FI
ContactHannu Ahjopalo
CorrespondentHannu Ahjopalo
INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland,  FI
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-24
Decision Date1991-05-23

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