ARIATELE TELEMETRY TRANSMITTER (96281)

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 Ariatele Telemetry Transmitter (96281).

Pre-market Notification Details

Device IDK121480
510k NumberK121480
Device Name:ARIATELE TELEMETRY TRANSMITTER (96281)
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  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-18
Decision Date2012-06-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10841522122088 K121480 000
10841522100581 K121480 000

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