SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810

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 Full Disclosure System, Model 91810.

Pre-market Notification Details

Device IDK063490
510k NumberK063490
Device Name:SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
ClassificationComputer, Diagnostic, Programmable
Applicant SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah,  WA  98029
ContactDavid J Geraghty
CorrespondentDavid J Geraghty
SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah,  WA  98029
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-17
Decision Date2007-03-15
Summary:summary

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