SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

Computer, Diagnostic, Programmable

SPACELABS HEALTHCARE LTD.

The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Sentinel Cardiology Information Management System.

Pre-market Notification Details

Device IDK152881
510k NumberK152881
Device Name:SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant SPACELABS HEALTHCARE LTD. 1 HARFORDE COURT JOHN TATE ROAD Hertford,  GB Sg13 7nw
ContactAl Van Houdt
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 Received2015-09-30
Decision Date2016-04-01
Summary:summary

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