PRESS-MATE BX-10 VITAL SIGN MONITOR

System, Measurement, Blood-pressure, Non-invasive

COLIN MEDICAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Colin Medical Instruments Corp. with the FDA for Press-mate Bx-10 Vital Sign Monitor.

Pre-market Notification Details

Device IDK032857
510k NumberK032857
Device Name:PRESS-MATE BX-10 VITAL SIGN MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant COLIN MEDICAL INSTRUMENTS CORP. 5850 FARINON DR. San Antonio,  TX  78249
ContactMark Rison
CorrespondentRobert Mosenkis
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-09-12
Decision Date2004-02-04
Summary:summary

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