PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III

Detector And Alarm, Arrhythmia

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Pc Arrhythmia Detection/analysis - Arrhythmia Iii.

Pre-market Notification Details

Device IDK860980
510k NumberK860980
Device Name:PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
ClassificationDetector And Alarm, Arrhythmia
Applicant SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
ContactHans, P.e.
CorrespondentHans, P.e.
SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-11
Decision Date1986-05-21

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