ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION

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

SPACELABS MEDICAL INC.

The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Elance Vital Signs Monitor And Elance Central Station.

Pre-market Notification Details

Device IDK093501
510k NumberK093501
Device Name:ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah,  WA  98029
ContactDavid Geraghty
CorrespondentDavid Geraghty
SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah,  WA  98029
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-12
Decision Date2009-11-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522125744 K093501 000
10841522113116 K093501 000

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