AS/3 TM NETWORK

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

DATEX DIVISION INSTRUMENTARIUM CORP.

The following data is part of a premarket notification filed by Datex Division Instrumentarium Corp. with the FDA for As/3 Tm Network.

Pre-market Notification Details

Device IDK933284
510k NumberK933284
Device Name:AS/3 TM NETWORK
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant DATEX DIVISION INSTRUMENTARIUM CORP. 27 TEOLLISUUSKATU Helsinki,  FI
ContactHannu Ahjopalo
CorrespondentHannu Ahjopalo
DATEX DIVISION INSTRUMENTARIUM CORP. 27 TEOLLISUUSKATU Helsinki,  FI
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-06
Decision Date1994-07-11

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