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510(k) K853990

Device
OSM3 HEMOXIMETER
Applicant
RADIOMETER AMERICA, INC.
510(k) number
K853990
Product code
JKS  
Decision
Substantially Equivalent (SESE)
Decision date
1985-12-30
Date received
1985-09-27
Regulation
862.3220
Classification name
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GERALD L VEDAA
Address
811 Sharon Dr. Westlake OH US 44145 44145

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JKS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951485AVOXIMETER 4000A-Vox Systems, Inc.1995-11-06
K863825CO-OXIMETER SOLUTIONSD.R.G. Scientific Industries1986-11-24
K862253IL 482 CO-OXIMETERInstrumentation Laboratory CO1986-07-29
K833693TEE ADAPTER 9890-FLUSH WINDING 282Shaban Mfg. Co.1983-12-30
K833211BILE SALTS MIXTUREAcumedia Manufacturers, Inc.1983-10-27
K832066CONTROL 282Bio-Nustics, Inc.1983-09-29
K780652HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2The London Co.1978-07-27

Legacy Summary#

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FDA Review#

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