SPACELABS MEDICAL ECG ANALYSIS SYSTEM

Computer, Diagnostic, Programmable

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Ecg Analysis System.

Pre-market Notification Details

Device IDK962930
510k NumberK962930
Device Name:SPACELABS MEDICAL ECG ANALYSIS SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactRuss Garrison
CorrespondentRuss Garrison
SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond,  WA  98073 -9713
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-29
Decision Date1997-04-25
Summary:summary

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