SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM

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 Spacelabs Medical Ultraview Digital Telemtry System.

Pre-market Notification Details

Device IDK983996
510k NumberK983996
Device Name:SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant SPACELABS MEDICAL, INC. 15220 N.E. 40TH ST. Redmond,  WA  98073 -9713
ContactNancy J Gertlar
CorrespondentNancy J Gertlar
SPACELABS MEDICAL, INC. 15220 N.E. 40TH ST. Redmond,  WA  98073 -9713
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-10
Decision Date1999-06-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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