PATIENT CARE MANAGEMENT SYSTEM MODIFICATION

Echocardiograph

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Patient Care Management System Modification.

Pre-market Notification Details

Device IDK910029
510k NumberK910029
Device Name:PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
ClassificationEchocardiograph
Applicant SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactRaymond Gifford
CorrespondentRaymond Gifford
SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
Product CodeDXK  
CFR Regulation Number870.2330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-03
Decision Date1991-01-31

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