SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390

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 Qube Compact Monitor (91390.

Pre-market Notification Details

Device IDK120616
510k NumberK120616
Device Name:SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant SPACELABS MEDICAL, INC. PO BOX 3018 Nederland,  CO  80466
ContactThomas Kroenke
CorrespondentThomas Kroenke
SPACELABS MEDICAL, INC. PO BOX 3018 Nederland,  CO  80466
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-29
Decision Date2012-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522127328 K120616 000
10841522127311 K120616 000
10841522127304 K120616 000
10841522100239 K120616 000
10841522100550 K120616 000
10841522102554 K120616 000
10841522100574 K120616 000

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