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 IDK050605
510k NumberK050605
Device Name:SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
ClassificationDetector And Alarm, Arrhythmia
Applicant SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, Wa,  WA  98027 -7018
ContactAl Van Houdt
CorrespondentAl Van Houdt
SPACELABS MEDICAL INC. 5150 220TH AVE SE PO BOX 7018 Issaquah, Wa,  WA  98027 -7018
Product CodeDSI  
Subsequent Product CodeDPZ
Subsequent Product CodeDQA
Subsequent Product CodeDSK
Subsequent Product CodeDXG
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-10
Decision Date2005-05-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.