SPACELABS-GENERAL SYSTEM LINK

Computer, Diagnostic, Programmable

SPACELABS, INC.

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

Pre-market Notification Details

Device IDK850627
510k NumberK850627
Device Name:SPACELABS-GENERAL SYSTEM LINK
ClassificationComputer, Diagnostic, Programmable
Applicant SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
ContactAllen M Hans
CorrespondentAllen M Hans
SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-19
Decision Date1985-05-28

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