SPACELABS PATHFINDER SL HOLTER ANALYZER

Computer, Diagnostic, Programmable

SPACELABS HEALTHCARE LTD.

The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Spacelabs Pathfinder Sl Holter Analyzer.

Pre-market Notification Details

Device IDK110001
510k NumberK110001
Device Name:SPACELABS PATHFINDER SL HOLTER ANALYZER
ClassificationComputer, Diagnostic, Programmable
Applicant SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland,  CO  80466
ContactThomas Kroenke
CorrespondentThomas Kroenke
SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland,  CO  80466
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-03
Decision Date2011-06-14
Summary:summary

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