HEARTRATE PLUS ECG CARDULE #1918

Detector And Alarm, Arrhythmia

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Heartrate Plus Ecg Cardule #1918.

Pre-market Notification Details

Device IDK830306
510k NumberK830306
Device Name:HEARTRATE PLUS ECG CARDULE #1918
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 Received1983-01-31
Decision Date1983-03-17

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