SPACELABS MEDICAL MULTIPARAMETER MODULE 91496

Detector And Alarm, Arrhythmia

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Multiparameter Module 91496.

Pre-market Notification Details

Device IDK050175
510k NumberK050175
Device Name:SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
ClassificationDetector And Alarm, Arrhythmia
Applicant SPACELABS MEDICAL, INC. 5150 220TH AVE SE P.O. BOX 7018 Issaquah,  WA  98027 -7018
ContactAl Van Houdt
CorrespondentAl Van Houdt
SPACELABS MEDICAL, INC. 5150 220TH AVE SE P.O. BOX 7018 Issaquah,  WA  98027 -7018
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-26
Decision Date2005-03-04
Summary:summary

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