ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841

System, Network And Communication, Physiological Monitors

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Ultraview Waveform Pager System, Model 91841.

Pre-market Notification Details

Device IDK992749
510k NumberK992749
Device Name:ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond,  WA  98052
ContactNancy Gertlar
CorrespondentNancy Gertlar
SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond,  WA  98052
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-16
Decision Date2000-01-14
Summary:summary

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