SPACELABS' SYSTEM AUTORECORDER

Recorder, Paper Chart

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs' System Autorecorder.

Pre-market Notification Details

Device IDK811540
510k NumberK811540
Device Name:SPACELABS' SYSTEM AUTORECORDER
ClassificationRecorder, Paper Chart
Applicant SPACELABS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDSF  
CFR Regulation Number870.2810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-01
Decision Date1981-08-13

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