Spacelabs Lifescreen PRO Analyzer

Computer, Diagnostic, Programmable

Spacelabs Healthcare Ltd.

The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Spacelabs Lifescreen Pro Analyzer.

Pre-market Notification Details

Device IDK201921
510k NumberK201921
Device Name:Spacelabs Lifescreen PRO Analyzer
ClassificationComputer, Diagnostic, Programmable
Applicant Spacelabs Healthcare Ltd. Unit B, Foxholes Centre, John Tate Road Hertford,  GB Sg13 7dt
ContactRoger Moldon
CorrespondentThomas Kroenke
Speed To Market, Inc. PO Box 3018 Nederland,  CO  80466
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-10
Decision Date2021-03-26

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