506CN PATIENT MONITOR

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

CRITICARE SYSTEMS, INC.

The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for 506cn Patient Monitor.

Pre-market Notification Details

Device IDK091050
510k NumberK091050
Device Name:506CN PATIENT MONITOR
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha,  WI  53186
ContactAlex Kaplan
CorrespondentAlex Kaplan
CRITICARE SYSTEMS, INC. 20925 CROSSROADS CIRCLE Waukesha,  WI  53186
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-13
Decision Date2009-05-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D438506DNBUS0 K091050 000
B438560DNUS0 K091050 000

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