DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

DATEX-OHMEDA

The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda S/5 Anesthesia Monitor With L-an03 And L-ane03a Software.

Pre-market Notification Details

Device IDK030812
510k NumberK030812
Device Name:DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant DATEX-OHMEDA 86 PILGRIM RD. Needham,  MA  02492
ContactJoel Kent
CorrespondentJoel Kent
DATEX-OHMEDA 86 PILGRIM RD. Needham,  MA  02492
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-14
Decision Date2003-05-21
Summary:summary

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