DELTATRAC(TM) II METABOLIC MONITOR

Computer, Oxygen-uptake

DATEX DIVISION INSTRUMENTARIUM CORP.

The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for Deltatrac(tm) Ii Metabolic Monitor.

Pre-market Notification Details

Device IDK931422
510k NumberK931422
Device Name:DELTATRAC(TM) II METABOLIC MONITOR
ClassificationComputer, Oxygen-uptake
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 CodeBZL  
CFR Regulation Number868.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-22
Decision Date1993-11-24

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