SPACELABS SMART DISCLOSURE SYSTEM

Computer, Diagnostic, Programmable

SPACELABS HEALTHCARE

The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Spacelabs Smart Disclosure System.

Pre-market Notification Details

Device IDK110779
510k NumberK110779
Device Name:SPACELABS SMART DISCLOSURE SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant SPACELABS HEALTHCARE P.O. BOX 3018 Nederland,  CO  80466
ContactThomas Kroenke
CorrespondentThomas Kroenke
SPACELABS HEALTHCARE P.O. BOX 3018 Nederland,  CO  80466
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-21
Decision Date2011-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522123580 K110779 000
10841522123597 K110779 000

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