PRESS-MATE PM-2100 VITAL SIGN MONITOR

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

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 Pm-2100 Vital Sign Monitor.

Pre-market Notification Details

Device IDK022537
510k NumberK022537
Device Name:PRESS-MATE PM-2100 VITAL SIGN MONITOR
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
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 CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2002-08-01
Decision Date2002-09-13
Summary:summary

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