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510(k) K112173

Device
SPEACELABS MULTIGAS MODULE
Applicant
SPACELABS HEALTHCARE
510(k) number
K112173
Product code
CBR  
Decision
Substantially Equivalent (SESE)
Decision date
2011-10-05
Date received
2011-07-28
Regulation
868.1700
Classification name
Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
THOMAS KROENKE
Address
P.O. Box 3018 Nederland CO US 80466 80466

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CBR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K053599SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIESSpacelabs Medical, Inc.2006-04-19
K954962SPACELABS MEDICAL MULTIGAS ANALYZERSpacelabs, Inc.1996-05-31
K904843OSCAR(TM) II CAPNOMETER & PULSE OXIMETERDalton Instrument Corp.1991-04-09
K853360N20 TESTErich Jaeger, Inc.1985-09-03

Legacy Summary#

summary

FDA Review#

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