APEXPRO FH TELEMETRY SYSTEM

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

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Apexpro Fh Telemetry System.

Pre-market Notification Details

Device IDK033365
510k NumberK033365
Device Name:APEXPRO FH TELEMETRY SYSTEM
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactDiana M Thorson
CorrespondentDiana M Thorson
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-21
Decision Date2003-11-06
Summary:summary

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