HEART RATE VARIABILITY SOFTWARE OPTION

Electrocardiograph

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Heart Rate Variability Software Option.

Pre-market Notification Details

Device IDK950779
510k NumberK950779
Device Name:HEART RATE VARIABILITY SOFTWARE OPTION
ClassificationElectrocardiograph
Applicant SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactRuss Garrison
CorrespondentRuss Garrison
SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-21
Decision Date1995-04-25

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