SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE

System, Measurement, Blood-pressure, Non-invasive

SPACELABS HEALTHCARE LTD.

The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Spacelbs Model On Trak (90227) Ambulatory Bloody Pressure (abp) Non-invasive.

Pre-market Notification Details

Device IDK141113
510k NumberK141113
Device Name:SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland,  CO  80466
ContactAl Van Houdt
CorrespondentAl Van Houdt
SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland,  CO  80466
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-30
Decision Date2014-09-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522129254 K141113 000
10841522102530 K141113 000
10841522102257 K141113 000
10841522102240 K141113 000
10841522102233 K141113 000
10841522128790 K141113 000
10841522129629 K141113 000
10841522129612 K141113 000
10841522129605 K141113 000
10841522129582 K141113 000
10841522129261 K141113 000
10841522102547 K141113 000
10841522105074 K141113 000
10841522129230 K141113 000
10841522129223 K141113 000
10841522126864 K141113 000
10841522123375 K141113 000
10841522123368 K141113 000
10841522123351 K141113 000
10841522123344 K141113 000
10841522123337 K141113 000
10841522123177 K141113 000
10841522107719 K141113 000
10841522129247 K141113 000

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