506 NON-INVASIVE VITAL SIGNS MONITOR

Detector And Alarm, Arrhythmia

CRITICARE SYSTEMS, INC.

The following data is part of a premarket notification filed by Criticare Systems, Inc. with the FDA for 506 Non-invasive Vital Signs Monitor.

Pre-market Notification Details

Device IDK884216
510k NumberK884216
Device Name:506 NON-INVASIVE VITAL SIGNS MONITOR
ClassificationDetector And Alarm, Arrhythmia
Applicant CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee,  WI  53226
ContactDer Ruhr
CorrespondentDer Ruhr
CRITICARE SYSTEMS, INC. P.O. BOX 26556 Milwaukee,  WI  53226
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-06
Decision Date1989-03-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B438506LNVP30 K884216 000
B438506LNP30 K884216 000
B438506DNVP30 K884216 000
B438506DNP3US0 K884216 000

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