SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)

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 Spacelabs Healthcare Xprezzon Beside Monitor(9913930).

Pre-market Notification Details

Device IDK112962
510k NumberK112962
Device Name:SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah,  WA  98029
ContactDavvid J Geraghty
CorrespondentDavvid J Geraghty
SPACELABS MEDICAL INC. 5150 220TH AVE SE Issaquah,  WA  98029
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-05
Decision Date2011-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522104565 K112962 000
10841522104534 K112962 000
10841522100093 K112962 000
10841522100109 K112962 000
10841522100079 K112962 000
10841522126024 K112962 000
10841522131035 K112962 000
10841522129179 K112962 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.