MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

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

SPACELABS MEDICAL INC.

The following data is part of a premarket notification filed by Spacelabs Medical Inc. with the FDA for Modification To Mcare 300 Vital Signs Monitor, Model 91220.

Pre-market Notification Details

Device IDK082045
510k NumberK082045
Device Name:MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant SPACELABS MEDICAL INC. 2235 EAST FLAMINGO RD. SUITE 201G Las Vegas,  NV  89119
ContactTim Davis
CorrespondentTim Davis
SPACELABS MEDICAL INC. 2235 EAST FLAMINGO RD. SUITE 201G Las Vegas,  NV  89119
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-18
Decision Date2008-08-01
Summary:summary

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