TYPE PDU/CDU 9040 (SYSTEM ATHENA)

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

S & W MEDICO TEKNIK

The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type Pdu/cdu 9040 (system Athena).

Pre-market Notification Details

Device IDK894700
510k NumberK894700
Device Name:TYPE PDU/CDU 9040 (SYSTEM ATHENA)
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
ContactLisbeth Isbrandt
CorrespondentLisbeth Isbrandt
S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark,  DK
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-24
Decision Date1989-10-02

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