Elance Vital Signs Monitor, Central Monitor Software

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

SPACELABS HEALTHCARE

The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Elance Vital Signs Monitor, Central Monitor Software.

Pre-market Notification Details

Device IDK150329
510k NumberK150329
Device Name:Elance Vital Signs Monitor, Central Monitor Software
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant SPACELABS HEALTHCARE 35301 SE CENTER STREET Snoqualmie,  WA  98065
ContactAl Van Houdt
CorrespondentThomas Kroenke
Speed To Market, Inc. PO Box 3018 Nederland,  CO  80466
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-10
Decision Date2015-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522128479 K150329 000
10841522128462 K150329 000
10841522128455 K150329 000

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