SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842

Index-generating Electroencephalograph Software

SPACELABS MEDICAL INC.

The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Spacelabs Medical Bispectral Index (bisx) Analysis Module 91482 And Accessories Model-91842.

Pre-market Notification Details

Device IDK060900
510k NumberK060900
Device Name:SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
ClassificationIndex-generating Electroencephalograph Software
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 CodeOLW  
Subsequent Product CodeOLT
Subsequent Product CodeOMC
Subsequent Product CodeORT
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-03
Decision Date2006-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522100253 K060900 000
10841522108754 K060900 000

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