SPACELABS HEALTHCARE CARDIOEXPRESS

Electrocardiograph

SPACELABS HEALTHCARE LTD.

The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Spacelabs Healthcare Cardioexpress.

Pre-market Notification Details

Device IDK130207
510k NumberK130207
Device Name:SPACELABS HEALTHCARE CARDIOEXPRESS
ClassificationElectrocardiograph
Applicant SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland,  CO  80466
ContactThomas Kroenke
CorrespondentThomas Kroenke
SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland,  CO  80466
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-28
Decision Date2013-07-23
Summary:summary

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