QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52

Detector And Alarm, Arrhythmia

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Quest Exercise Stress System (quest), Version 3.52.

Pre-market Notification Details

Device IDK021097
510k NumberK021097
Device Name:QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
ClassificationDetector And Alarm, Arrhythmia
Applicant SPACELABS MEDICAL, INC. 1730 PENNSYLVANIA AVE. NW Washington,  DC  20006
ContactEdward M Basile
CorrespondentEdward M Basile
SPACELABS MEDICAL, INC. 1730 PENNSYLVANIA AVE. NW Washington,  DC  20006
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-04
Decision Date2002-06-28
Summary:summary

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