ARRHYTHMIA II CARDULE

Detector And Alarm, Arrhythmia

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Arrhythmia Ii Cardule.

Pre-market Notification Details

Device IDK790837
510k NumberK790837
Device Name:ARRHYTHMIA II CARDULE
ClassificationDetector And Alarm, Arrhythmia
Applicant SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-30
Decision Date1979-05-16

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