MODELS M1175A AND M1176A COMPONENT MONITORING SYST

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

HEWLETT-PACKARD CO.

The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Models M1175a And M1176a Component Monitoring Syst.

Pre-market Notification Details

Device IDK922058
510k NumberK922058
Device Name:MODELS M1175A AND M1176A COMPONENT MONITORING SYST
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany,  DE
ContactGerhard Lenke
CorrespondentGerhard Lenke
HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany,  DE
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-22
Decision Date1992-10-06

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