FDA.reportPublic FDA data

510(k) K904843

Device
OSCAR(TM) II CAPNOMETER & PULSE OXIMETER
Applicant
DALTON INSTRUMENT CORP.
510(k) number
K904843
Product code
CBR  
Decision
Substantially Equivalent (SESE)
Decision date
1991-04-09
Date received
1990-10-25
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
RAUNO RUOHO
Address
P.O. Box 357 Sf-00101 Helsinki, Finland FI

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
K853360N20 TESTErich Jaeger, Inc.1985-09-03

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases