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510(k) K853360

Device
N20 TEST
Applicant
ERICH JAEGER, INC.
510(k) number
K853360
Product code
CBR  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-03
Date received
1985-08-12
Regulation
868.1700
Classification name
Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RONALD EVENSON
Address
5251 Zenith Pkwy. Rockford IL US 61111 61111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CBR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K112173SPEACELABS MULTIGAS MODULESpacelabs Healthcare2011-10-05
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

Legacy Summary#

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FDA Review#

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