ARRHYTHMIA II EDITOR

Computer, Diagnostic, Programmable

SPACELABS, INC.

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

Pre-market Notification Details

Device IDK791776
510k NumberK791776
Device Name:ARRHYTHMIA II EDITOR
ClassificationComputer, Diagnostic, Programmable
Applicant SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-09-10
Decision Date1979-10-02

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