SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE

Computer, Blood-pressure

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs P.c. Cardiac Output/pressure Module.

Pre-market Notification Details

Device IDK860689
510k NumberK860689
Device Name:SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
ClassificationComputer, Blood-pressure
Applicant SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactHans, P.e.
CorrespondentHans, P.e.
SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
Product CodeDSK  
CFR Regulation Number870.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-25
Decision Date1986-07-30

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