VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

CRITICARE SYSTEMS, INC.

The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for Vital Signs Monitor W/arrhythmia Detection And St Analysis, Model 8100.

Pre-market Notification Details

Device IDK030613
510k NumberK030613
Device Name:VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha,  WI  53186
ContactAlex Kaplan
CorrespondentAlex Kaplan
CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha,  WI  53186
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-26
Decision Date2003-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B4388100EUS0 K030613 000
B4388100EPUS0 K030613 000
B4388100EPST0 K030613 000
B4388100EP1US0 K030613 000
B4388100EP1ST0 K030613 000
B4388100E1US0 K030613 000
B4388100E1ST0 K030613 000

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