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510(k) K053599

Device
SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
Applicant
SPACELABS MEDICAL INC.
510(k) number
K053599
Product code
CBR  
Decision
Substantially Equivalent (SESE)
Decision date
2006-04-19
Date received
2005-12-23
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
AL VAN HOUDT
Address
5150 220th Ave. SE Issaquah WA US 98029 98029

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
K112173SPEACELABS MULTIGAS MODULESpacelabs Healthcare2011-10-05
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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