SPACELABS HEALTHCARE TELEMETRY RECEIVER

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 Spacelabs Healthcare Telemetry Receiver.

Pre-market Notification Details

Device IDK141156
510k NumberK141156
Device Name:SPACELABS HEALTHCARE TELEMETRY RECEIVER
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant SPACELABS HEALTHCARE P.O. BOX 3018 Nederland,  CO  80466
ContactThomas Kroenke
CorrespondentThomas Kroenke
SPACELABS HEALTHCARE P.O. BOX 3018 Nederland,  CO  80466
Product CodeMHX  
Subsequent Product CodeDSI
Subsequent Product CodeMLD
Subsequent Product CodeMSX
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-05
Decision Date2014-09-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522124754 K141156 000
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10841522102868 K141156 000
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10841522102714 K141156 000
10841522102707 K141156 000
10841522102691 K141156 000
10841522120220 K141156 000
10841522120237 K141156 000
10841522102721 K141156 000
10841522102882 K141156 000
10841522127052 K141156 000
10841522127045 K141156 000
10841522127038 K141156 000
10841522127021 K141156 000
10841522120282 K141156 000
10841522120275 K141156 000
10841522120268 K141156 000
10841522120251 K141156 000
10841522120244 K141156 000
10841522100246 K141156 000

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